跳至主要内容
临床试验/NCT06382402
NCT06382402撤回不适用

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

University of Louisville1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年5月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dinesh Kalra, MD

Professor

University of Louisville

研究点 (1)

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