Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
study withdrawn, no participant enrolled, change in the study design planned
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Hospitalized patients diagnosed with type 2 NSTEMI.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dinesh Kalra, MD | University of Louisville School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville School of Medicine, Division of Cardiovascular Diseases | Louisville | Kentucky | 40202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |