Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT03936660
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2019-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christopher.granger@duke.edu', 'phone': '9196688700', 'title': 'Chris Granger, MD', 'organization': 'Duke Clinical Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months.', 'description': "Per protocol, each site reported adverse events to Boehringer-Ingelheim (BI)'s pharmacovigilance team. Not all end point data were reported as adverse events.", 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.', 'otherNumAtRisk': 459, 'deathsNumAtRisk': 459, 'otherNumAffected': 4, 'seriousNumAtRisk': 459, 'deathsNumAffected': 6, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.', 'otherNumAtRisk': 590, 'deathsNumAtRisk': 590, 'otherNumAffected': 1, 'seriousNumAtRisk': 590, 'deathsNumAffected': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 590, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 Months', 'description': 'Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c \\< 7%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom medication data was available at 6 or 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Prescribed high-intensity statin', 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}]}, {'title': 'Prescribed ACEI or ARB', 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}]}, {'title': 'Prescribed SGLT-2i and/or GLP-1RA', 'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}, {'title': 'Prescribed 2 or more groups of recommended medications (composite score >= 2)', 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}]}, {'title': 'Prescribed all 3 groups (without metformin monotherapy option)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 Months', 'description': 'Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom medication data was available at 6 or 12 months.'}, {'type': 'SECONDARY', 'title': 'Change in Average LDL-C From Baseline to Last Follow-up Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '72.93', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '75.07', 'spread': '30.66', 'groupId': 'OG001'}]}]}, {'title': 'Last follow-up visit', 'categories': [{'measurements': [{'value': '68.79', 'spread': '31.17', 'groupId': 'OG000'}, {'value': '70.60', 'spread': '32.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Average change in LDL-C values between baseline visit and last follow-up visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom medication data was available at 6 or 12 months, and who had cholesterol data available at baseline and last follow-up.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With LDL-C < 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Last follow-up visit', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in number of participants with LDL-C \\< 70 mg/dL at baseline visit vs. last follow-up visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with outcome data available at both baseline and last follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Change in Average Blood Pressure From Baseline to Last Follow-up Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Baseline systolic blood pressure', 'categories': [{'measurements': [{'value': '131.40', 'spread': '16.14', 'groupId': 'OG000'}, {'value': '129.47', 'spread': '16.48', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up systolic blood pressure', 'categories': [{'measurements': [{'value': '129.09', 'spread': '17.36', 'groupId': 'OG000'}, {'value': '130.35', 'spread': '17.00', 'groupId': 'OG001'}]}]}, {'title': 'Baseline diastolic blood pressure', 'categories': [{'measurements': [{'value': '74.04', 'spread': '10.28', 'groupId': 'OG000'}, {'value': '72.35', 'spread': '10.90', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up diastolic blood pressure', 'categories': [{'measurements': [{'value': '72.44', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '72.01', 'spread': '11.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in systolic and diastolic blood pressure from baseline to last follow-up visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom medication data was available at 6 or 12 months, who had systolic and diastolic blood pressure data at baseline and last follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With sBP < 130 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}]}, {'title': 'Last follow-up visit', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Proportion of participants achieving sBP \\< 130 mmHg at baseline vs. last follow-up visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with outcome data available at both baseline and last follow-up visits'}, {'type': 'SECONDARY', 'title': 'Number of Participants With dBP < 180 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}]}]}, {'title': 'Last follow-up visit', 'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in number of participants with dBP \\< 180 mmHg from baseline to last follow-up visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with outcome data available at both baseline and last follow-up visit'}, {'type': 'SECONDARY', 'title': 'Change in Average HbA1c From Baseline to Last Follow-up Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Provided with existing clinical care guidelines.'}], 'classes': [{'title': 'HbA1c at baseline', 'categories': [{'measurements': [{'value': '7.64', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c at last follow-up visit', 'categories': [{'measurements': [{'value': '7.47', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.', 'unitOfMeasure': 'HbA1c %', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom medication data was available at 6 or 12 months, and who had HbA1c values available at baseline and last follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HbA1c < 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}]}, {'title': 'Last follow-up visit', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in number of participants with HbA1c \\< 7% from baseline to last follow-up visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with outcome data available at both baseline and last follow-up visit'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing an Event Within 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Provided with existing clinical care guidelines.'}], 'classes': [{'title': 'Composite (all-cause mortality, MI, stroke, urgent revascularization, decompensated HF)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'All-cause mortality', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization for myocardial infarction (MI)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization for stroke', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization for urgent revascularization', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization for decompensated heart failure (HF)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Months', 'description': 'Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom medication data was available at 6 or 12 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Provided with existing clinical care guidelines.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '25', 'numSubjects': '459'}, {'groupId': 'FG001', 'numUnits': '24', 'numSubjects': '590'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '25 sites randomized, of which, 5 sites dropped out prior to enrolling participants.', 'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '457'}, {'comment': '24 sites randomized, of which, 1 site dropped out prior to enrolling participants.', 'groupId': 'FG001', 'numUnits': '23', 'numSubjects': '588'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Missing medication data at 6 and 12 months.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'Sites'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '590', 'groupId': 'BG001'}, {'value': '1049', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '76'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '64', 'upperLimit': '77'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '63', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '711', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '550', 'groupId': 'BG001'}, {'value': '941', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health Insurance', 'classes': [{'title': 'Medicare (alone or with other insurance)', 'categories': [{'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '410', 'groupId': 'BG001'}, {'value': '692', 'groupId': 'BG002'}]}]}, {'title': 'Private only', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}, {'title': 'Medicaid only', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Other insurance only', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'No insurance', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Composite Medication Score', 'classes': [{'title': '0 points (not taking any recommended medications)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': '1 point (taking one recommended medication)', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}, {'title': '2 points (taking two recommended medications)', 'categories': [{'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of recommended medications being taken by the participant at baseline.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-25', 'size': 375372, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-01T13:36', 'hasProtocol': True}, {'date': '2022-06-16', 'size': 404792, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-01T13:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1049}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2019-05-01', 'resultsFirstSubmitDate': '2023-06-07', 'studyFirstSubmitQcDate': '2019-05-01', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-15', 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications', 'timeFrame': 'Up to 12 Months', 'description': 'Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c \\< 7%.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.', 'timeFrame': 'Up to 12 Months', 'description': 'Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.'}, {'measure': 'Change in Average LDL-C From Baseline to Last Follow-up Visit.', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Average change in LDL-C values between baseline visit and last follow-up visit.'}, {'measure': 'Number of Participants With LDL-C < 70 mg/dL', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in number of participants with LDL-C \\< 70 mg/dL at baseline visit vs. last follow-up visit.'}, {'measure': 'Change in Average Blood Pressure From Baseline to Last Follow-up Visit.', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in systolic and diastolic blood pressure from baseline to last follow-up visit.'}, {'measure': 'Number of Participants With sBP < 130 mmHg', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Proportion of participants achieving sBP \\< 130 mmHg at baseline vs. last follow-up visit'}, {'measure': 'Number of Participants With dBP < 180 mmHg', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in number of participants with dBP \\< 180 mmHg from baseline to last follow-up visit'}, {'measure': 'Change in Average HbA1c From Baseline to Last Follow-up Visit.', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.'}, {'measure': 'Number of Participants With HbA1c < 7%', 'timeFrame': 'Baseline and last follow-up visit (up to 12 months)', 'description': 'Change in number of participants with HbA1c \\< 7% from baseline to last follow-up visit.'}, {'measure': 'Number of Participants Experiencing an Event Within 1 Year', 'timeFrame': 'Up to 12 Months', 'description': 'Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COORDINATE-DIABETES', 'COORDINATE', 'T2DM', 'Diabetes Mellitus, Type 2', 'Cardiovascular Disease', 'Prevention'], 'conditions': ['Diabetes Mellitus, Type 2', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '26981940', 'type': 'BACKGROUND', 'citation': 'Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1094. doi: 10.1056/NEJMc1600827. No abstract available.'}, {'pmid': '27295427', 'type': 'BACKGROUND', 'citation': 'Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.'}, {'pmid': '28545639', 'type': 'BACKGROUND', 'citation': 'Sattar N, Petrie MC, Zinman B, Januzzi JL Jr. Novel Diabetes Drugs and the Cardiovascular Specialist. J Am Coll Cardiol. 2017 May 30;69(21):2646-2656. doi: 10.1016/j.jacc.2017.04.014.'}, {'pmid': '28859942', 'type': 'BACKGROUND', 'citation': 'Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28.'}, {'pmid': '30559235', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.'}, {'pmid': '30559236', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S103-S123. doi: 10.2337/dc19-S010.'}, {'pmid': '38934111', 'type': 'DERIVED', 'citation': 'Tannu M, Kaltenbach L, Pagidipati NJ, McGuire DK, Aroda VR, Pop-Busui R, Kondamudi N, Al-Khalidi HR, Lopes RD, Cavender MA, Nelson AJ, Kirk J, Lingvay I, Magwire M, Richardson CR, Webb L, Leyva M, Pandey A, Washington A, Pak J, Gaynor T, Khan W, Weston P, Granger CB, Green J. Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial. Circulation. 2024 Jul 16;150(3):180-189. doi: 10.1161/CIRCULATIONAHA.124.068962. Epub 2024 Jun 27.'}, {'pmid': '36877177', 'type': 'DERIVED', 'citation': 'Pagidipati NJ, Nelson AJ, Kaltenbach LA, Leyva M, McGuire DK, Pop-Busui R, Cavender MA, Aroda VR, Magwire ML, Richardson CR, Lingvay I, Kirk JK, Al-Khalidi HR, Webb L, Gaynor T, Pak J, Senyucel C, Lopes RD, Green JB, Granger CB; COORDINATE-Diabetes Site Investigators. Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1261-1270. doi: 10.1001/jama.2023.2854.'}]}, 'descriptionModule': {'briefSummary': 'COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.', 'detailedDescription': 'Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize a minimum of 42 US cardiology clinics to an intervention arm vs. control arm. The clinic-level multi-faceted educational intervention will include strategies to develop cardiology and endocrinology partnerships and guideline-recommended care pathways with measurement and feedback to improve the care of patients with type 2 diabetes mellitus and cardiovascular disease.\n\nPatients must be enrolled during a routine visit in a cardiology clinic, and the clinic must have at least 3 physicians and/or APPs on staff with independent patient populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Diagnosis of Type 2 diabetes mellitus (T2DM)\n* History of at least one of the following conditions:\n\n 1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)\n 2. Stroke and/or carotid artery stenosis (≥50%)\n 3. Peripheral Arterial disease (defined as claudication with ABI\\<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)\n* Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization\n\nExclusion Criteria:\n\n* Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator\n* GFR\\<30 mL/min/1.73m2\n* Already on all guideline-recommended therapies for T2DM and CVD\n* Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD'}, 'identificationModule': {'nctId': 'NCT03936660', 'acronym': 'COORDINATE', 'briefTitle': 'A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes', 'orgStudyIdInfo': {'id': 'Pro00101556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Clinics provided with existing clinical care guidelines.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.', 'interventionNames': ['Other: Intense Education Intervention']}], 'interventions': [{'name': 'Intense Education Intervention', 'type': 'OTHER', 'otherNames': ['Intervention'], 'description': 'Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Grandview Health/Alabama Cardiovascular Group', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'USA Cardiology', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Heart and Vascular Institute', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dignity Health/DHMG Specialty Medicine', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Blue Coast Cardiology', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80012', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Denver Cardiology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '32714', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Heart and Vascular Institute', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Riverside Medical Center/Synergy Healthcare', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Lennar Foundation/Univ. of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Citrus Cardiology', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32258', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health Research Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research for Health Improvement, LLC', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32401', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiovascular Inst. of Northwest Florida', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Bayfront Cardiovascular Associates', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '34655', 'city': 'Trinity', 'state': 'Florida', 'country': 'United States', 'facility': 'Interventional Cardiac Consultants', 'geoPoint': {'lat': 28.18085, 'lon': -82.68177}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory/Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Heart Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62208', 'city': 'Fairview Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advanced Heart Care Group/Medicoricium LLC', 'geoPoint': {'lat': 38.58894, 'lon': -89.99038}}, {'zip': '60461', 'city': 'Olympia Fields', 'state': 'Illinois', 'country': 'United States', 'facility': 'Specialty Physicians of Illinois', 'geoPoint': {'lat': 41.51337, 'lon': -87.67421}}, {'zip': '61606', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'UnityPoint Health Cardiovascular Services', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Cardiovascular Consultants', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '50266', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Heart Clinic of Louisiana', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49707', 'city': 'Alpena', 'state': 'Michigan', 'country': 'United States', 'facility': 'Endeavor Medical Research', 'geoPoint': {'lat': 45.06168, 'lon': -83.43275}}, {'zip': '48507', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cardiology Institute of Michigan', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '63401', 'city': 'Hannibal', 'state': 'Missouri', 'country': 'United States', 'facility': 'Hannibal Regional Medical Group', 'geoPoint': {'lat': 39.70838, 'lon': -91.35848}}, {'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Heartcare LLC', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'zip': '07036', 'city': 'Linden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Heart', 'geoPoint': {'lat': 40.62205, 'lon': -74.24459}}, {'zip': '07726', 'city': 'Manalapan', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Garden State Heart Care', 'geoPoint': {'lat': 40.25733, 'lon': -74.39571}}, {'zip': '08080', 'city': 'Sewell', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cardiovascular Associates of the Delaware Valley', 'geoPoint': {'lat': 39.7665, 'lon': -75.14434}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health/Lenox Hill Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '27215', 'city': 'Burlington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Kernodle Clinic', 'geoPoint': {'lat': 36.09569, 'lon': -79.4378}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cape Fear Heart Associates', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '73134', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cardiovascular Health Clinic', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Guthrie Medical Group', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '29646', 'city': 'Greenwood', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Advanced Cardiology Associates', 'geoPoint': {'lat': 34.1954, 'lon': -82.16179}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills Cardiovascular Research', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ. of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Lonestar Heart and Vascular', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '53188', 'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'ProHealth Care Heart and Vascular', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}], 'overallOfficials': [{'name': 'Christopher Granger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}