Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-06 @ 4:06 AM
Study NCT ID:
NCT03861533
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003430', 'term': 'Cross-Sectional Studies'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2422}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving country specific guideline-recommended LDL-C levels after 18 month final visit or last available observation during follow up visits.', 'timeFrame': 'LDL-C target after 18 month final visit', 'description': 'the outcome variable, LDL-C, will be presented with mean and standard deviation'}], 'secondaryOutcomes': [{'measure': '1. Relative and absolute reduction of LDL-C with lipid lowering medications added during the observation period.', 'timeFrame': 'The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture', 'description': 'the outcome variable, LDL-C, will be presented with mean and standard deviation'}, {'measure': 'Proportion of patients not achieving recommended LDL-C level based on high risk inclusion sub-group (e.g. FH), co-morbid conditions (diabetes mellitus), baseline treatment or baseline lipid profile.', 'timeFrame': 'The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture', 'description': 'the outcome variable, LDL-C, will be presented with mean and standard deviation'}, {'measure': 'Proportion of patients not achieving recommended LDL-C level at each of the follow up visits according to physician responses as to why country specific recommendation for LDL-C lowering opportunities was not followed.', 'timeFrame': 'The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture', 'description': 'the outcome variable, LDL-C, will be presented with mean and standard deviation'}, {'measure': 'Proportion of patients achieving LDL-C and non-HDL level across participating countries.', 'timeFrame': 'The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture', 'description': 'the outcome variable, LDL-C, will be presented with mean and standard deviation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This Quality Enhancement Research Initiative (QuERI) is a knowledge translation medical practice activity based on decision making support through feedback to physicians on their management of dyslipidemia in order to achieve guidelines recommended LDL-C levels in high risk patients. Physician interaction has three distinct components:\n\n1. Capture of data as reported by participating physician;\n2. Highlight (by providing feedback) where management may be optimized based on guidelines or recommendations;\n3. Identify challenges faced by physicians resulting in the care gap..', 'detailedDescription': 'The GOAL QuERI International will engage approximately 115 health care practitioners (HCP) who will enroll up to 2500 patients with management observations based on four visits by the patients in an outpatient setting. The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture form (DCF). The DCF will be created and managed by the CHRC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'GOAL International enrolling approximately 2500 patients with clinical vascular disease or familial hypercholesterolemia (FH) and LDL-C \\> 2.0 mmol/L (77 mg/dl) despite maximally tolerated statin therapy. As part of an interactive knowledge translation component, physicians are asked to indicate their next steps in lowering of LDL-C and are then asked whether they will be following the guidelines and if not why not.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥ 18 years old\n2. High risk for cardiovascular morbidity and mortality such as prior history of clinical cardiovascular disease and/or history of familial hypercholesterolemia\n3. LDL-C within the past 6 months above recommended level despite maximal tolerated statin therapy ± ezetimibe for the past 3 months.\n\nExclusion Criteria:\n\n1. Current treatment with PCSK9 inhibitor\n2. Current participation in investigational study\n3. Prior participation in the GOAL program'}, 'identificationModule': {'nctId': 'NCT03861533', 'acronym': 'GOAL QuERI', 'briefTitle': 'GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Heart Research Centre'}, 'officialTitle': 'Guidelines Oriented Approach to Lipid Lowering Quality Enhancement Research Initiative (GOAL QuERI) International', 'orgStudyIdInfo': {'id': 'CHRC2019-GOAL INT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'OTHER', 'otherNames': ['cross-sectional study without specific intervention'], 'description': 'Cross-Reference'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Sabah Hosptial', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}, {'city': 'Querétaro City', 'state': 'Querétaro', 'country': 'Mexico', 'facility': 'Centro de Estudios Clínicos de Querétaro (CECLIQ)', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}, {'zip': '31932', 'city': 'Dhahran', 'country': 'Saudi Arabia', 'facility': 'King Fahd Military Medical Complex', 'geoPoint': {'lat': 26.28864, 'lon': 50.11396}}, {'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Anatoly Langer, MD, M.Sc, FRCP(C,) FACC', 'role': 'STUDY_CHAIR', 'affiliation': 'Canadian Heart Rersearch Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Anatoly Langer', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, M.Sc., FRCP (C), FACC', 'investigatorFullName': 'Dr. Anatoly Langer', 'investigatorAffiliation': 'Canadian Heart Research Centre'}}}}