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

Coronary Artery Disease Clinical Trial

— ACOVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00921856
• Other study ID #: ACOVA-1
• Secondary ID: ACOVA-2
• Status: Recruiting
• Phase: N/A
• Start date: November 2007
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Robert Bosch Medical Center
• Contact: Peter Ong, MD
• Phone: +4971181015449
• Email: petereong[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Vasospasm
• Microvascular Angina
• Myocardial Ischemia

Intervention

Other:
• Intracoronary acetylcholine provocation test
Intracoronary provocation of coronary spasm with acetylcholine in augmented dosages of 2 µg, 20 µg, 100 µg and 200 µg non-selectively in the LCA as well as 80 µg in the RCA. During the procedure, a 12 channel ECG will be recorded.

Locations

Country	Name	City	State
Germany	Robert Bosch Medical Center	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
Peter Ong, MD	Deutsche Stiftung für Herzforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality (cardiac vs. non-cardiac)		12-120 months
Secondary	Angina pectoris, repeated angiography, re-admissions for angina pectoris		12-120 months