Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-12 @ 1:22 PM
Study NCT ID:
NCT06382402
Status:
WITHDRAWN
Last Update Posted:
2025-03-17
First Post:
2024-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'study withdrawn, no participant enrolled, change in the study design planned', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': 'anytime within 3 years', 'description': 'Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups.\n\nUnit: no unit (yes/no)'}, {'measure': 'Cardiovascular (CV) mortality', 'timeFrame': 'anytime within 3 years', 'description': 'Cardiovascular (CV) mortality Unit: no unit (yes/no)'}, {'measure': 'Nonfatal MI, stroke', 'timeFrame': 'anytime within 3 years', 'description': 'Nonfatal MI, stroke Unit: no unit (yes or no)'}, {'measure': 'Hospitalization for unstable angina', 'timeFrame': 'anytime within 3 years', 'description': 'Hospitalization for unstable angina Unit: no unit (yes or no)'}, {'measure': 'Hospitalization for heart failure', 'timeFrame': 'anytime within 3 years', 'description': 'Hospitalization for heart failure Unit: no unit (yes or no)'}, {'measure': 'Unplanned revascularization', 'timeFrame': 'anytime within 3 years', 'description': 'Unplanned revascularization Unit: no unit (yes or no)'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'anytime within 3 years', 'description': 'All-cause mortality Unit: no unit (yes or no)'}, {'measure': 'In-hospital and 90-day costs', 'timeFrame': 'anytime within 90 days', 'description': 'In-hospital and 90-day costs Unit: US dollars'}, {'measure': 'Patient quality of life at 90 days', 'timeFrame': 'anytime within 90 days', 'description': 'Patient quality of life at 90 days Unit: The numeric rating scales'}, {'measure': 'Diagnostic certainty scores', 'timeFrame': 'anytime within 3 years', 'description': 'Diagnostic certainty scores Unit: The numeric rating scores'}, {'measure': 'Individual components of the primary endpoint', 'timeFrame': 'anytime within 3 years', 'description': 'Individual components of the primary endpoint Unit: no unit (yes or no)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myocardial Injury']}, 'descriptionModule': {'briefSummary': 'This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI.', 'detailedDescription': "This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI. Patients are randomized into 2 groups. Group 1 undergoes coronary 64-detector row computed tomography angiography (CCTA) and Group 2 receives conservative management and treatment for underlying conditions. The investigators will evaluate cross-sectional and time-varying clinical, laboratory, and imaging characteristics in association with clinical events. The exclusion criteria are an absence of information for follow-up of clinical events, and patients who have absolute and relative contraindications for CCTA. Absolute contraindications are a patient history of severe or anaphylactic reaction to iodinated contrast, inability to cooperate with scan protocols, hemodynamic instability, decompensated heart failure, acute myocardial infarction, and renal impairment with GFR \\< 30. Relative contraindications include pregnancy, inability to tolerate heart rate-slowing medications or nitroglycerin, recent phosphodiesterase inhibitor use, severe aortic stenosis, bronchospastic disease, and patient's weight and height."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients diagnosed with type 2 NSTEMI.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inpatient with type 2 NSTEMI\n* Aged 18-70 years old\n* At the University of Louisville and Jewish hospitals\n\nExclusion Criteria:\n\n* History of severe or anaphylactic reaction to iodinated contrast\n* Inability to cooperate with scan protocols\n* Hemodynamic instability\n* Decompensated heart failure\n* Acute myocardial infarction\n* Renal impairment with GFR \\< 30\n* Pregnancy\n* Inability to tolerate heart rate-slowing medications or nitroglycerin\n* Recent phosphodiesterase inhibitor use\n* Severe aortic stenosis\n* Bronchospastic disease\n* Patient's weight and height"}, 'identificationModule': {'nctId': 'NCT06382402', 'briefTitle': 'A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Randomized Control Trial of Outcomes Comparing a Coronary Computed Tomography Angiography (CCTA) Guided Management Strategy Versus a Standard of Care Strategy in Type 2 Non-ST-elevation MI', 'orgStudyIdInfo': {'id': '23.0924'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CCTA Group', 'description': 'CT group will undergo CCTA to evaluate for coronary artery disease to early address underlying CAD and then care will be directed based on the findings of that CT scan.', 'interventionNames': ['Radiation: CCTA scan']}, {'label': 'No CCTA Group', 'description': 'Group 2 will not undergo CCTA and will be managed at the discretion of the primary team using the standard of care pathway comprising of either conservative medical management, stress testing, or invasive evaluation with coronary angiography in the catheterization laboratory.'}], 'interventions': [{'name': 'CCTA scan', 'type': 'RADIATION', 'description': '• CCTA will be performed per the standard clinical protocol using a Cannon Aquilion ONE scanner with 16 cm z-axis coverage at 0.5 mm resolution, low contrast, and reduced radiation dose requirements.', 'armGroupLabels': ['CCTA Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville School of Medicine, Division of Cardiovascular Diseases', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Dinesh Kalra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dinesh Kalra, MD', 'investigatorAffiliation': 'University of Louisville'}}}}