A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI
- Conditions
- Myocardial Injury
- Interventions
- Radiation: CCTA scan
- Registration Number
- NCT06382402
- Lead Sponsor
- University of Louisville
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 700
- Inpatient with type 2 NSTEMI
- Aged 18-70 years old
- At the University of Louisville and Jewish hospitals
- 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
- Bronchospastic disease
- Patient's weight and height
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CCTA Group CCTA scan 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.
- Primary Outcome Measures
Name Time Method Cardiovascular (CV) mortality anytime within 3 years Cardiovascular (CV) mortality Unit: no unit (yes/no)
Nonfatal MI, stroke anytime within 3 years Nonfatal MI, stroke Unit: no unit (yes or no)
Hospitalization for unstable angina anytime within 3 years Hospitalization for unstable angina Unit: no unit (yes or no)
Hospitalization for heart failure anytime within 3 years Hospitalization for heart failure Unit: no unit (yes or no)
MACE 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 anytime within 3 years Unplanned revascularization Unit: no unit (yes or no)
- Secondary Outcome Measures
Name Time Method Diagnostic certainty scores anytime within 3 years Diagnostic certainty scores Unit: The numeric rating scores
All-cause mortality anytime within 3 years All-cause mortality Unit: no unit (yes or no)
In-hospital and 90-day costs anytime within 90 days In-hospital and 90-day costs Unit: US dollars
Patient quality of life at 90 days anytime within 90 days Patient quality of life at 90 days Unit: The numeric rating scales
Individual components of the primary endpoint anytime within 3 years Individual components of the primary endpoint Unit: no unit (yes or no)
Trial Locations
- Locations (2)
University of Louisville School of Medicine, Division of Cardiovascular Diseases
🇺🇸Louisville, Kentucky, United States
University of Louisville School of Medicine, Division of Cardiovascular Diseases
🇺🇸Louisville, Kentucky, United States