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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Myocardial Injury
- Sponsor
- University of Louisville
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Cardiovascular (CV) mortality
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dinesh Kalra, MD
Professor
University of Louisville
Eligibility Criteria
Inclusion Criteria
- •Inpatient with type 2 NSTEMI
- •Aged 18-70 years old
- •At the University of Louisville and Jewish hospitals
Exclusion Criteria
- •History of severe or anaphylactic reaction to iodinated contrast
- •Inability to cooperate with scan protocols
- •Hemodynamic instability
- •Decompensated heart failure
- •Acute myocardial infarction
- •Renal impairment with GFR \< 30
- •Pregnancy
- •Inability to tolerate heart rate-slowing medications or nitroglycerin
- •Recent phosphodiesterase inhibitor use
- •Severe aortic stenosis
Outcomes
Primary Outcomes
Cardiovascular (CV) mortality
Time Frame: anytime within 3 years
Cardiovascular (CV) mortality Unit: no unit (yes/no)
Nonfatal MI, stroke
Time Frame: anytime within 3 years
Nonfatal MI, stroke Unit: no unit (yes or no)
Hospitalization for unstable angina
Time Frame: anytime within 3 years
Hospitalization for unstable angina Unit: no unit (yes or no)
Hospitalization for heart failure
Time Frame: anytime within 3 years
Hospitalization for heart failure Unit: no unit (yes or no)
MACE
Time Frame: anytime within 3 years
Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups. Unit: no unit (yes/no)
Unplanned revascularization
Time Frame: anytime within 3 years
Unplanned revascularization Unit: no unit (yes or no)
Secondary Outcomes
- Diagnostic certainty scores(anytime within 3 years)
- All-cause mortality(anytime within 3 years)
- In-hospital and 90-day costs(anytime within 90 days)
- Patient quality of life at 90 days(anytime within 90 days)
- Individual components of the primary endpoint(anytime within 3 years)