NON-Invasive Examinations of Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
The aim of the study is to evaluate and compare the value of 5 different non-invasive diagnostic methods in patients with chest pain suspected for coronary artery disease. The investigators intend to include 200 patients over a 3 year period in the study. The participants will be recruited from patients referred to coronary angiography at the institution. Before the angiography the participants will (1) test the effect of sublingual Nitroglycerin, (2) give their medical history so mathematical models can estimate the probability of the presence of coronary artery disease, (3) take part in a contrast stress echocardiography and (4) a 2D-strain stress echocardiography and a myocardial scintigraphy. Stenosis found at the angiography will be the gold standard.
详细描述
The aim of the study is to evaluate the diagnostic value of various non-invasive methods. The study is divided into five substudies:
Substudy NITRO
Purpose: To investigate whether a subjective effect of Nitroglycerine is associated with significantly narrowed coronary arteries.
The participants are instructed to alternate between rest and Nitroglycerine as treatment for chest pain attacks during a 2 week period. Chest pain score is recorded in a diary handed out at day 1 together with 30 tablets Nitroglycerine in the maximal tolerated dose.
Substudy SCORE
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
- •Intermittent episodes of chest pain (more than two attacks, minimum one attack/week)
- •Signed written informed consent
- •Sinus rhythm (ECG)
- •Age above 18 years
排除标准
- •Previously (known) myocardial infarction or unstable angina with dynamic changes in the ECG or biomarkers (serology)
- •CA performed earlier in life
- •Known significant cardiac valve disease
- •Asthma (not COPD)
- •Incapable of performing an exercise test
- •Malignant Disease
- •Senile dementia or other conditions causing impaired cooperation
- •Previous participation in the project
- •NTG intolerance
- •Bundle branch block (QRS > 120 ms)
- •ECG changes:
- •Pathologic Q-wave in at least two leads:
- •QS-complex or Q-wave > 0.02 sec. in V2-V3
- •QS-complex or Q-wave > 0.03 sec. and > 0.1 mV in I, II, aVL, aVF or V4-V6
- •Pathologic negative T-wave (in V3-6 and I, II) unless this is part of a left ventricular hypertrophy and strain pattern
- •Brady pacemaker