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临床试验/NCT00921856
NCT00921856招募中不适用

Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries

Peter Ong, MD1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2007年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
all cause mortality (cardiac vs. non-cardiac)

研究概览

简要总结

In patients with chest pain and/or shortness of breath coronary artery disease (CAD) is suspected depending on the pattern of symptoms and the electrocardiogram (ECG). Coronary angiography is the method of choice to verify this suspicion. If the patient coronary arteries on coronary angiography are totally normal or unobstructed, one can only speculate if the patients' discomfort is from the heart or not. A possibility to get further information about the healthiness of the coronary arteries is the acetylcholine test (ACH-test). When injecting this natural, body produced-substance into the coronary arteries one can test if the vessels develop coronary spasm which can be the reason for the patient's symptoms. The investigators therefore use this test in this study to look for coronary spasm in patients with suspected CAD but normal/unobstructed coronary arteries. In case of a positive test, the patient profits from having found a cause for his/her symptoms making treatment with special tablets possible. Furthermore, the investigators want to analyze blood samples of every patient to look for signs of inflammation, vasoconstriction and genetic variants that seem to be linked with coronary spasms. On the basis of these results the ACH-test could probably be avoided in the future.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults between 35 and 95 years old with angina pectoris and/or dyspnea suggestive of coronary artery disease with non-invasive proof of coronary ischemia or high pre-test probability for CAD who will be referred for coronary angiography
  • •Serum creatinine < 1,4 md/dl
  • •Left ventricular ejection fraction > 50%

排除标准

  • •Patients under 35 years and above 95 years of age
  • •Severe chronic obstructive pulmonary disease (contraindication for acetylcholine-testing)

研究组 & 干预措施

No-CAD

Experimental

Patients admitted with suspicion of CAD but without proof of CAD after coronary angiography will undergo intracoronary acetylcholine provocation test.

干预措施: Intracoronary acetylcholine provocation test (Other)

CAD

No Intervention

Patients admitted with suspicion of CAD and proof of CAD after coronary angiography.

结局指标

主要结局

all cause mortality (cardiac vs. non-cardiac)

时间窗: 12-120 months

次要结局

  • Angina pectoris, repeated angiography, re-admissions for angina pectoris(12-120 months)

研究者

发起方
Peter Ong, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter Ong, MD

Principal Investigator, PD Dr. med.

Robert Bosch Medical Center

研究点 (1)

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