Technical Performance of a New Cardiac Technology "IQ-SPECT" Applied to SCINTI-CT Myocardial Imaging With 99mTc-Sestamibi in Coronary Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Myocardial perfusion binding
研究概览
简要总结
Cardiological examination is one of the major directions in nuclear medicine for detection of myocardial ischemia in patients with suspected coronary artery disease. In Caen, they constitute 20% of the activity of nuclear medicine. It is evaluating a new versatile innovative technology (IQ-SPECT) for performing rapid nuclear cardiological examinations (4 minutes) and quality on a SCINTI-CT camera for correcting the mitigation. This technical solution IQ-SPECT was made available to the nuclear medicine department in August 2011. To date, apart from the work on heart ghosts and one publication in abstract form in 2009, no other study have been published.
The goal of the study is to study the technical performance of the innovative technology IQ-SPECT during a SCINTI-CT imaging in patients suspected of coronary disease .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •age over 18 years (except major patients under guardianship)
- •free and informed consent signed
- •written and spoken French
- •beneficiaries of the social security system
- •coronary insufficiency detection needed for patients with signs or symptoms suggestive of coronary insufficiency; or in symptomatic patients, but with a high risk of coronary heart disease: diabetes and / or with multiple cardiovascular risk factors and / or having a peripheral vascular disease
排除标准
- •Patients with a recent history (<21 days) acute coronary failure (myocardial infarction, unstable angina);
- •Patients with an irregular heartbeat, because of the impossibility of achieving a good quality ECG synchronization (atrial fibrillation, ventricular extra-systole or supraventricular over 25% of cardiac cycles);
- •Patients with a pacemaker with a permanent electro-drive at rest;
- •Patients with non-ischemic heart disease: primitive dilated cardiomyopathy, severe hypertrophic cardiomyopathy, severe valvular cardiomyopathy (aortic stenosis, aortic or mitral leakage grade> 2), congenital heart disease;
- •Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment);
- •Major patients under guardianship;
- •Pregnant or lactating women;
- •Women in age and condition of childbearing;
- •Patients unable to understand the purpose of the study.
- •Cons-indications to physical stress test:
- •Uncontrolled heart failure,
- •Pulmonary embolism, phlebitis evolution,
- •Myocarditis, pericarditis, endocarditis evolving
- •Physical disability,
- •contra-indication for exercise testing as dipyridamole:
- •Severe Asthma
研究组 & 干预措施
New Technology "IQ-SPECT" applied to myocardial imaging
干预措施: scintigraphic imaging (Device)
New Technology "IQ-SPECT" applied to myocardial imaging
干预措施: myocardial IQ-SPECT imaging applied to scintigraphic imaging (Device)
结局指标
主要结局
Myocardial perfusion binding
时间窗: baseline
* 0 = normal fixing ≥70% * 1 = slightly reduced mounting 50-69% * 2 = moderately less attachment 30-49% * 3 = severely diminished attachment 10-20% * 4 = no binding \<10%
次要结局
未报告次要终点