Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-31 @ 5:58 PM
Study NCT ID:
NCT01620658
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radioprotective Light-weight Caps in the Interventional Cardiology Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'raulh@baptisthealth.net', 'phone': '786-596-3505', 'title': 'Raul Herrera, MD. Director Miami Cardiac and Vascular Institute, Research and Outcomes', 'organization': 'Baptist Health South Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Cap', 'description': 'Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.\n\nStandard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '0.3mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '0.5mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiation Attenuation in Percentage (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Cap', 'description': 'Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.\n\nStandard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.'}, {'id': 'OG001', 'title': '0.3mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.'}, {'id': 'OG002', 'title': '0.5mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '19.1'}, {'value': '91.5', 'groupId': 'OG001', 'lowerLimit': '87.4', 'upperLimit': '95.6'}, {'value': '97.1', 'groupId': 'OG002', 'lowerLimit': '92.5', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean Radiation Protection is described under Outcome Measure Data below.'}, {'type': 'PRIMARY', 'title': 'Absolute Radiation Exposure Outside of Cap', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Exposure Monitored With Standard Caps.', 'description': 'Operators were randomly assigned to wear standard fabric Caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.'}, {'id': 'OG001', 'title': 'Radiation Exposure Monitored With XPF 0.3 mm Caps', 'description': 'Operators were randomly assigned to wear the 0.3 mm Caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.'}, {'id': 'OG002', 'title': 'Radiation Exposure Monitored With XPF 0.5mm Caps', 'description': 'Operators were randomly assigned to wear lead-equivalent XPF caps. Radiation doses were measured by using dosimeters placed outside and underneath the caps.'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '243'}, {'value': '118', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '183'}, {'value': '59', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.', 'unitOfMeasure': 'uSv', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary objective of the trial is to show how much radiation attenuation is provided by XPF in absolute and relative terms.'}, {'type': 'SECONDARY', 'title': 'Operator Comfort Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Caps', 'description': 'Operators were randomly assigned to wear standard fabric Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.'}, {'id': 'OG001', 'title': 'XPF 0.3 mm', 'description': 'Operators were randomly assigned to wear XPF 0.3mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.'}, {'id': 'OG002', 'title': 'XPF 0.5 mm', 'description': 'Operators were randomly assigned to wear XPF 0.5mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day per participant, a total of 197 operator days', 'description': 'After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operator Comfort Assessment Based on Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Caps', 'description': 'Operators were randomly assigned to wear standard fabric Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.'}, {'id': 'OG001', 'title': 'XPF 0.5 mm', 'description': 'Operators were randomly assigned to wear XPF 0.5mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.'}, {'id': 'OG002', 'title': 'XPF 0.3 mm', 'description': 'Operators were randomly assigned to wear XPF 0.3mm Caps. The operator comfort rating on the VAS (score range, 0-100), with higher numbers indicating better comfort, was obtained in all cases and for all operators.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '12.6'}, {'value': '123.7', 'groupId': 'OG001', 'lowerLimit': '122.9', 'upperLimit': '124.6'}, {'value': '118.4', 'groupId': 'OG002', 'lowerLimit': '116.7', 'upperLimit': '120.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day per participant, a total of 197 operator days', 'description': 'After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).', 'unitOfMeasure': 'grams', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Cap', 'description': 'Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.\n\nStandard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.'}, {'id': 'FG001', 'title': '0.3mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.'}, {'id': 'FG002', 'title': '0.5mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'Patients presenting to the Miami Cardiac and Vascular Institute for Imaging Study/Procedure.', 'preAssignmentDetails': 'Voluntary patient participation. PI responsible for patient selection.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Cap', 'description': 'Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.\n\nStandard cap: Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.'}, {'id': 'BG001', 'title': '0.3mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.3mm XPF cap: Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.'}, {'id': 'BG002', 'title': '0.5mm XPF Cap', 'description': 'Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\n0.5mm XPF cap: Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '65'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '65'}, {'value': '53', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '65'}, {'value': '53', 'groupId': 'BG003', 'lowerLimit': '40', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2012-06-06', 'resultsFirstSubmitDate': '2015-07-20', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-24', 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Attenuation in Percentage (%)', 'timeFrame': '1 day', 'description': 'The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100.'}, {'measure': 'Absolute Radiation Exposure Outside of Cap', 'timeFrame': '1 day', 'description': 'The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.'}], 'secondaryOutcomes': [{'measure': 'Operator Comfort Assessment', 'timeFrame': '1 day per participant, a total of 197 operator days', 'description': 'After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).'}, {'measure': 'Operator Comfort Assessment Based on Weight', 'timeFrame': '1 day per participant, a total of 197 operator days', 'description': 'After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Occupational Exposure to Radiation'], 'conditions': ['Occupational Exposure to Radiation']}, 'referencesModule': {'references': [{'pmid': '25982649', 'type': 'RESULT', 'citation': 'Uthoff H, Quesada R, Roberts JS, Baumann F, Schernthaner M, Zaremski L, Hajirawala L, Katzen BT, Staub D, Kreusch AS. Radioprotective lightweight caps in the interventional cardiology setting: a randomised controlled trial (PROTECT). EuroIntervention. 2015 May;11(1):53-9. doi: 10.4244/EIJV11I1A9.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.', 'detailedDescription': 'The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.\n\nFor more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Interventional Cardiologist practicing in Baptist Cardiac \\& Vascular Institute\n* cardiac procedure requiring C-arm fluoroscopy\n\nExclusion Criteria:\n\n* Interventional Neuroradiologists and Interventional Radiologists will not be included in this study.'}, 'identificationModule': {'nctId': 'NCT01620658', 'acronym': 'PROTECT', 'briefTitle': 'Radioprotective Light-weight Caps in the Interventional Cardiology Setting', 'organization': {'class': 'OTHER', 'fullName': 'Baptist Health South Florida'}, 'officialTitle': 'Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PROTECT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard cap', 'description': 'Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.', 'interventionNames': ['Device: Standard cap']}, {'type': 'EXPERIMENTAL', 'label': '0.3mm XPF cap', 'description': 'Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.', 'interventionNames': ['Device: 0.3mm XPF cap']}, {'type': 'EXPERIMENTAL', 'label': '0.5mm XPF cap', 'description': 'Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.', 'interventionNames': ['Device: 0.5mm XPF cap']}], 'interventions': [{'name': '0.5mm XPF cap', 'type': 'DEVICE', 'description': 'Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.', 'armGroupLabels': ['0.5mm XPF cap']}, {'name': '0.3mm XPF cap', 'type': 'DEVICE', 'description': 'Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.\n\nXPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.', 'armGroupLabels': ['0.3mm XPF cap']}, {'name': 'Standard cap', 'type': 'DEVICE', 'description': 'Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.', 'armGroupLabels': ['standard cap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami, Miami Cardiac and Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Raul Herrera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baptist Hospital of Miami, Miami Cardiac and Vascular Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baptist Health South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Clinical Research & Outcomes', 'investigatorFullName': 'Raul Herrera, MD', 'investigatorAffiliation': 'Baptist Health South Florida'}}}}