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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Myocardial Injury
• Intervention / Treatment: Radiation: CCTA scan

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville School of Medicine, Division of Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Hospitalized patients diagnosed with type 2 NSTEMI.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CCTA Group; 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.	Radiation: CCTA scan; • 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.
No CCTA Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups. Unit: no unit (yes/no)	anytime within 3 years
Cardiovascular (CV) mortality	Cardiovascular (CV) mortality Unit: no unit (yes/no)	anytime within 3 years
Nonfatal MI, stroke	Nonfatal MI, stroke Unit: no unit (yes or no)	anytime within 3 years
Hospitalization for unstable angina	Hospitalization for unstable angina Unit: no unit (yes or no)	anytime within 3 years
Hospitalization for heart failure	Hospitalization for heart failure Unit: no unit (yes or no)	anytime within 3 years
Unplanned revascularization	Unplanned revascularization Unit: no unit (yes or no)	anytime within 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality Unit: no unit (yes or no)	anytime within 3 years
In-hospital and 90-day costs	In-hospital and 90-day costs Unit: US dollars	anytime within 90 days
Patient quality of life at 90 days	Patient quality of life at 90 days Unit: The numeric rating scales	anytime within 90 days
Diagnostic certainty scores	Diagnostic certainty scores Unit: The numeric rating scores	anytime within 3 years
Individual components of the primary endpoint	Individual components of the primary endpoint Unit: no unit (yes or no)	anytime within 3 years

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Dinesh Kalra, MD, University of Louisville School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23.0924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes