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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Cardiovascular (CV) mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient with type 2 NSTEMI
- •Aged 18-70 years old
- •At the University of Louisville and Jewish hospitals
排除标准
- •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
结局指标
主要结局
Cardiovascular (CV) mortality
时间窗: anytime within 3 years
Cardiovascular (CV) mortality Unit: no unit (yes/no)
Nonfatal MI, stroke
时间窗: anytime within 3 years
Nonfatal MI, stroke Unit: no unit (yes or no)
Hospitalization for unstable angina
时间窗: anytime within 3 years
Hospitalization for unstable angina Unit: no unit (yes or no)
Hospitalization for heart failure
时间窗: anytime within 3 years
Hospitalization for heart failure Unit: no unit (yes or no)
MACE
时间窗: anytime within 3 years
Time to the first major adverse cardiac event (MACE) at 3 years between 2 groups. Unit: no unit (yes/no)
Unplanned revascularization
时间窗: anytime within 3 years
Unplanned revascularization Unit: no unit (yes or no)
次要结局
- Diagnostic certainty scores(anytime within 3 years)
- 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)
- Individual components of the primary endpoint(anytime within 3 years)
研究者
Dinesh Kalra, MD
Professor
University of Louisville
