Myocardial Injury
Conditions
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.
Interventions
RADIATIONCCTA 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.
Sponsors
University of Louisville
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned revascularization | anytime within 3 years | Unplanned revascularization Unit: no unit (yes or no) |
| MACE | anytime within 3 years | Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups. Unit: no unit (yes/no) |
| Cardiovascular (CV) mortality | anytime within 3 years | Cardiovascular (CV) mortality Unit: no unit (yes/no) |
| Nonfatal MI, stroke | anytime within 3 years | Nonfatal MI, stroke Unit: no unit (yes or no) |
| Hospitalization for unstable angina | anytime within 3 years | Hospitalization for unstable angina Unit: no unit (yes or no) |
| Hospitalization for heart failure | anytime within 3 years | Hospitalization for heart failure Unit: no unit (yes or no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital and 90-day costs | anytime within 90 days | In-hospital and 90-day costs Unit: US dollars |
| Patient quality of life at 90 days | anytime within 90 days | Patient quality of life at 90 days Unit: The numeric rating scales |
| Diagnostic certainty scores | anytime within 3 years | Diagnostic certainty scores Unit: The numeric rating scores |
| Individual components of the primary endpoint | anytime within 3 years | Individual components of the primary endpoint Unit: no unit (yes or no) |
| All-cause mortality | anytime within 3 years | All-cause mortality Unit: no unit (yes or no) |
Countries
United States
Outcome results
None listed