Abnormal Coronary Vasomotion in Patients With Suspected Coronary Artery Disease (CAD)

Not Applicable

Recruiting

• Conditions: Coronary Vasospasm; Microvascular Angina; Coronary Artery Disease
• Interventions: Other: Intracoronary acetylcholine provocation test

• Registration Number: NCT00921856
• Lead Sponsor: Peter Ong, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-16
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-31
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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%

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No-CAD	Intracoronary acetylcholine provocation test	Patients admitted with suspicion of CAD but without proof of CAD after coronary angiography will undergo intracoronary acetylcholine provocation test.

Primary Outcome Measures

Name	Time	Method
all cause mortality (cardiac vs. non-cardiac)	12-120 months

Secondary Outcome Measures

Name	Time	Method
Angina pectoris, repeated angiography, re-admissions for angina pectoris	12-120 months

Trial Locations

Locations (1)

Robert Bosch Medical Center; 🇩🇪 Stuttgart, Germany