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

NCT00921856 | Unknown

• 2 other identifiers: ACOVA-1ACOVA-2
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Acetylcholine

Outcome Measures

Primary Outcomes (1)

• all cause mortality (cardiac vs. non-cardiac)

  12-120 months

Secondary Outcomes (1)

• Angina pectoris, repeated angiography, re-admissions for angina pectoris

  12-120 months

Study Arms (2)

CAD

NO INTERVENTION

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

No-CAD

EXPERIMENTAL

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

Other: Intracoronary acetylcholine provocation test

Interventions

Intracoronary acetylcholine provocation test 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.

No-CAD

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Peter Ong, MD: lead
• Deutsche Stiftung für Herzforschung: collaborator

Study Sites (1)

Robert Bosch Medical Center

Stuttgart, 70376, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 22322081 DERIVED

MeSH Terms

Conditions

Coronary Vasospasm; Microvascular Angina; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Peter Ong, MD

  Robert Bosch Medical Center

  PRINCIPAL INVESTIGATOR

• Andreas Seitz, MD

  Robert Bosch Medical Center

  STUDY CHAIR

• Udo Sechtem, MD

  Robert Bosch Medical Center

  STUDY DIRECTOR

Central Study Contacts

Peter Ong, MD

CONTACT

+4971181015449; petereong@gmail.com

Andreas Seitz, MD

CONTACT

+4971181015585

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, PD Dr. med.

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 16, 2009
• Study Start: November 1, 2007
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

DE (1)