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

NCT06382402 | Withdrawn FDA Device

• 1 other identifier: 23.0924
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Injury

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

• Diagnostic certainty scores

  anytime within 3 years

• Individual components of the primary endpoint

  anytime within 3 years

Study Arms (2)

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

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.

Interventions

CCTA scan RADIATION

• 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.

CCTA Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients diagnosed with type 2 NSTEMI.

You may qualify if:

• Inpatient with type 2 NSTEMI
• Aged 18-70 years old
• At the University of Louisville and Jewish hospitals

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville School of Medicine, Division of Cardiovascular Diseases

Louisville, Kentucky, 40202, United States

Location

Study Officials

• Dinesh Kalra, MD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)