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

NCT ID: NCT00921856

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2025-12-31

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.

Conditions

Coronary Vasospasm; Microvascular Angina; Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CAD

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

No-CAD

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

Group Type: EXPERIMENTAL

Intracoronary acetylcholine provocation test

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche Stiftung für Herzforschung

OTHER

Sponsor Role: collaborator

Peter Ong, MD

OTHER

Sponsor Role: lead

Responsible Party

Peter Ong, MD

Principal Investigator, PD Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter Ong, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Bosch Medical Center

Andreas Seitz, MD

Role: STUDY_CHAIR

Robert Bosch Medical Center

Udo Sechtem, MD

Role: STUDY_DIRECTOR

Robert Bosch Medical Center

Locations

Robert Bosch Medical Center

Stuttgart, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Peter Ong, MD

Role: CONTACT

petereong@gmail.com

+4971181015449

Andreas Seitz, MD

Role: CONTACT

+4971181015585

Facility Contacts

Peter Ong, MD

Role: primary

petereong@gmail.com

+4971181016048

Anastasios Athanasiadis, MD

Role: backup

+4971181015444

References

Ong P, Athanasiadis A, Borgulya G, Mahrholdt H, Kaski JC, Sechtem U. High prevalence of a pathological response to acetylcholine testing in patients with stable angina pectoris and unobstructed coronary arteries. The ACOVA Study (Abnormal COronary VAsomotion in patients with stable angina and unobstructed coronary arteries). J Am Coll Cardiol. 2012 Feb 14;59(7):655-62. doi: 10.1016/j.jacc.2011.11.015.

Reference Type: DERIVED

PMID: 22322081 (View on PubMed)

Other Identifiers

ACOVA-2

Identifier Type: OTHER

Identifier Source: secondary_id

ACOVA-1

Identifier Type: -

Identifier Source: org_study_id