A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI
- Conditions
- Myocardial Injury
- 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- WITHDRAWN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
- 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 (1)
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