Clinical trial NCT06382402: A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myocardial Injury
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients diagnosed with type 2 NSTEMI.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACE
timeFrame: anytime within 3 years
measure: Cardiovascular (CV) mortality
timeFrame: anytime within 3 years
measure: Nonfatal MI, stroke
timeFrame: anytime within 3 years
measure: Hospitalization for unstable angina
timeFrame: anytime within 3 years
measure: Hospitalization for heart failure
timeFrame: anytime within 3 years
measure: Unplanned revascularization
timeFrame: anytime within 3 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: anytime within 3 years
measure: In-hospital and 90-day costs
timeFrame: anytime within 90 days
measure: Patient quality of life at 90 days
timeFrame: anytime within 90 days
measure: Diagnostic certainty scores
timeFrame: anytime within 3 years
measure: Individual components of the primary endpoint
timeFrame: anytime within 3 years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases
state: Kentucky
Study officials:
affiliation: University of Louisville School of Medicine
name: Dinesh Kalra, MD
role: PRINCIPAL_INVESTIGATOR
References: