Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 7:04 PM
Study NCT ID:
NCT07283666
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-16
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subspecialty Ambulatory Quality Cardiology Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients eligible for medications who are prescribed these medications', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with HFrEF prescribed aldosterone antagonists', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of patients with Afib prescribed oral anticoagulants', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Reduced Ejection Fraction', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Investigators will evaluate the effectiveness of an audit and feedback performance improvement strategy in which cardiology providers receive quarterly emails on ambulatory quality improvement goals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen by a cardiology provider in the ambulatory setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for atrial fibrillation quality metric:\n\n* Active diagnosis of atrial fibrillation\n* CHADS2VASC of at least 2 in males and at least 3 in females\n* Outpatient cardiology visit in past 3 months\n\nInclusion Criteria for HFrEF quality metric:\n\n* Most recent EF ≤40\n* Age 18-90\n* Outpatient cardiology visit in past 3 months\n\nExclusion Criteria for atrial fibrillation quality metric:\n\n* LAAO device\n* Hemorrhagic Stroke\n\nExclusion Criteria for HFrEF quality metric:\n\n* SBP\\<90\n* eGFR\\<30\n* Potassium\\>5\n* Active allergy to MRA\n* Acknowledge reason on heart failure alert\n* Mechanical circulatory device\n* Cardiac amyloid diagnosis'}, 'identificationModule': {'nctId': 'NCT07283666', 'briefTitle': 'Subspecialty Ambulatory Quality Cardiology Program', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Subspecialty Ambulatory Quality Cardiology Program: An Audit and Feedback Performance Improvement Strategy', 'orgStudyIdInfo': {'id': 'QI-Specialty Ambulatory'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Quarterly Emails', 'description': 'Quarterly emails on performance will be sent.'}, {'label': 'Control', 'description': 'Usual Care (no emails on performance).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Amrita Mukhopadhyay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a quality improvement (QI) project and individual participant data (IPD) will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}