Prognostic Value of High Dose Dobutamine Stress Magnetic Resonance in Patients With Ischemic Heart Disease. Assessment of Myocardial Perfusion and Wall Motion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Cardiac death and nonfatal myocardial infarction (MACEs)
研究概览
简要总结
High-dose dobutamine/atropine stress cardiac magnetic resonance imaging (DS-MRI) has been incorporated in daily clinical practice for the detection of ischemic heart disease.
Thus, wall motion abnormalities (WMA) during stress, precede the development of ST-segment depression on ECG and of anginal symptoms and aid in the detection of anatomically significant coronary artery disease (CAD).
DS-MRI offers the possibility to integrate myocardial perfusion and wall motion analysis in a single examination. In this regard, recent data suggest that the assessment of myocardial wall motion and perfusion during a single session may enhance the sensitivity of the technique for the diagnosis of CAD.
However, to date limited data is available on the prognostic value of high-dose DS-MRI in large patient cohorts, treated according to current guidelines.
Assessment of long-term outcome of DS-MRI is important because this test may identify both high-risk patients, who would benefit from invasive diagnostic and therapy, and lower-risk patients in whom additional procedures and intensive medical follow-up are not required.
In the present study we aim to determine the value of wall motion and perfusion assessment during high-dose dobutamine/atropine MRI in predicting cardiac events.
In addition, the incremental value of the MR-stress testing results was assessed (inducible wall motion, perfusion abnormalities and the combination of both) after the consideration of traditional clinical risk factors and baseline ejection fraction.
详细描述
Background: High-dose dobutamine stress cardiac magnetic resonance imaging (DS-MRI) is incorporated in daily clinical practice for the detection of coronary artery disease (CAD). Purpose: To determine the value of wall motion and perfusion assessment during DS-MRI for the prediction of cardiac events in a large patient cohort.
Methods:
Cardiovascular MR-Examination. Patients are examined in a clinical 1.5-T whole-body MR-scanner Achieva system (Philips Medical Systems, Best, The Netherlands) using a 5-element cardiac phased-array receiver coil. Cardiovascular MR-images were acquired at rest and during a standardized high-dose dobutamine/atropine protocol involving short breath holds, and using a vector electrocardiogram for R-wave triggering11. Electrocardiographic rhythm and symptoms were monitored continuously, and blood pressure was measured every 3 minutes.
Follow-up Data. Personnel unaware of the stress testing results contacts each subject or an immediate family member and the date of this contact was used for calculating the follow-up time duration. Outcome data iscollected from a standardized questionnaire and determined from patient interviews at the outpatient clinic or by telephone interviews. Reported clinical events are confirmed by review of the corresponding medical records in our electronic Hospital Information System (HIS), contact with the general practitioner, referring cardiologist or the treating hospital. Cardiac death and nonfatal myocardial infarction are registered as major cardiac events. Cardiac death is defined as death from any cardiac cause (lethal arrhythmia, myocardial infarction, or congestive heart failure) or sudden unexpected death occurring without another explanation. Myocardial infarction is defined by angina of >30 minutes duration and either ST segment elevation of ≥2mm in 2 consecutive ECG leads or a rise in troponin T of ≥0.03µg/l.
Other events include clinically indicated coronary arterial revascularization by percutaneous coronary angioplasty (PCI) or coronary artery bypass graft (CABG).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent before the MR-examination
排除标准
- •Non-sinus rhythm, unstable angina, severe arterial hypertension (>200/120 mmHg), moderate or severe valvular disease and general contraindications to MRI (implanted pacemakers or defibrillators, intracranial metal)
结局指标
主要结局
Cardiac death and nonfatal myocardial infarction (MACEs)
时间窗: 2-5 years of follow-up
次要结局
- Late revascularization (90 days after the MR-examination)(2-5 yrs.)
研究者
G. Korosoglou
Prof. Dr.
Heidelberg University
