A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI

University of Louisville

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Myocardial Injury

Interventions

CCTA scanRADIATION

• 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 * Bronchospastic disease * Patient's weight and height

Locations (1)

University of Louisville School of Medicine, Division of Cardiovascular Diseases

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

MACE

Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups. Unit: no unit (yes/no)