Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
The primary objective of this study is to analyze the clinical value of a therapeutic management strategy based on the results of coronary CT angiography and functional MRI. The clinical value of CT and MRI will be analyzed in patients with suspected coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected coronary artery disease and planned conventional coronary angiography based on atypical angina pectoris
排除标准
- •Known coronary artery disease
- •ST elevation
- •Age below 30 years
- •Women of child-bearing potential without a negative pregnancy test
- •Inclusion in another study
- •Heart rate above 70 beats per min and contraindications to beta blockers
- •Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block
- •Inability to hold the breath for 10 s
研究组 & 干预措施
CT/MR
CT/MRI-directed clinical management strategy
干预措施: CT/MR (Procedure)
Catheterization
Standard clinical management
干预措施: Catheterization (Procedure)
结局指标
主要结局
Complications
时间窗: during or up to 2 days after procedures
Death, stroke, and myocardial infarction and moderate to severe groin hematoma, groin pain, infections, allergies, thromboses, and arteriovenous fistula or other complications (if prolonging the in-hospital stay significantly by at least 24 hours).
次要结局
- Hard Cardiovascular Events(Follow-up 3 (36-60 Months))
- Comparison of Contrast Induced Nephropathy(Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months))
- Comparison of Comparison of Soft Cardiovascular Events(Follow-up 3 (36-60, Months))
- Comparison of In-Hospital Stay(Up to 24 hours after the end of the in-hospital stay.)
- Quality of Life Analysis(Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months))
- Confounding Effects of Nutrition, Physical Activity, and Depression(Follow-up 1 (6-12 Months), Follow-up 2 (12-24 Months), Follow-up 3 (36-60 Months))
- Comparison of Cost-effectiveness(Follow-up 3 (36-60 Months))
- Comparison of Patient Preference(24 hours after last procedure related to computed tomography or conventional coronary angiography)
- Comparison of the Amount of Contrast Agent(10 minutes after the examinations.)
- Comparison of the Amount of Radiation Exposure(Comparison of the amount of radiation exposure)
- Analysis of Image Quality(Up to 24 hours after the end of computed tomography)
- Analysis of Correlation and Agreement About the Stenosis Diameter Between Multislice Computed Coronary Angiography and Conventional Coronary Angiography(Up to 24 hours after the end of computed tomography)
- Comparison of Biological Effects of Radiation Exposure(Z1) before exam, (Z2) 60 min after end of exam, (Z3) 18-24h after exam)
研究者
Marc Dewey
Professor
Charite University, Berlin, Germany