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

Myocardial Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382402
• Other study ID #: 23.0924
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: University of Louisville
• Contact: Dinesh Kalra, MD
• Phone: 502-588-7010
• Email: dinesh.kalra[@]louisville.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Injury

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville School of Medicine, Division of Cardiovascular Diseases	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cardiovascular (CV) mortality	Cardiovascular (CV) mortality Unit: no unit (yes/no)	anytime within 3 years
Primary	Nonfatal MI, stroke	Nonfatal MI, stroke Unit: no unit (yes or no)	anytime within 3 years
Primary	Hospitalization for unstable angina	Hospitalization for unstable angina Unit: no unit (yes or no)	anytime within 3 years
Primary	Hospitalization for heart failure	Hospitalization for heart failure Unit: no unit (yes or no)	anytime within 3 years
Primary	Unplanned revascularization	Unplanned revascularization Unit: no unit (yes or no)	anytime within 3 years
Secondary	All-cause mortality	All-cause mortality Unit: no unit (yes or no)	anytime within 3 years
Secondary	In-hospital and 90-day costs	In-hospital and 90-day costs Unit: US dollars	anytime within 90 days
Secondary	Patient quality of life at 90 days	Patient quality of life at 90 days Unit: The numeric rating scales	anytime within 90 days
Secondary	Diagnostic certainty scores	Diagnostic certainty scores Unit: The numeric rating scores	anytime within 3 years
Secondary	Individual components of the primary endpoint	Individual components of the primary endpoint Unit: no unit (yes or no)	anytime within 3 years