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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Robert Bosch Medical Center
Information provided by (Responsible Party):
Peter Ong, MD, Robert Bosch Medical Center Identifier:
First received: June 8, 2009
Last updated: November 2, 2015
Last verified: November 2015
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, 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 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 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 that seem to be linked with coronary spasms. On the basis of these results the ACH-test could probably be avoided in the future.

Condition Intervention
Coronary Vasospasm
Microvascular Angina
Coronary Artery Disease
Other: Intracoronary acetylcholine provocation test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries

Resource links provided by NLM:

Further study details as provided by Robert Bosch Medical Center:

Primary Outcome Measures:
  • all cause mortality (cardiac vs. non-cardiac) [ Time Frame: 12-36 months ]

Secondary Outcome Measures:
  • Angina pectoris, repeated angiography, re-admissions for angina pectoris [ Time Frame: 12-36 months ]

Estimated Enrollment: 320
Study Start Date: November 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CAD
Patients admitted with suspicion of CAD and proof of CAD after coronary angiography.
Experimental: No-CAD
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
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.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00921856

Contact: Peter Ong, MD +447745624863
Contact: Anastasios Athanasiadis, MD +4971181015444

Robert Bosch Medical Center Recruiting
Stuttgart, Germany, 70376
Contact: Peter Ong, MD    +447745624863   
Contact: Anastasios Athanasiadis, MD    +4971181015444      
Sponsors and Collaborators
Peter Ong, MD
Principal Investigator: Peter Ong, MD Robert Bosch Medical Center
Study Chair: Anastasios Athanasiadis, MD Robert Bosch Medical Center
Study Director: Udo Sechtem, MD Robert Bosch Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peter Ong, MD, Funktionsoberarzt, Robert Bosch Medical Center Identifier: NCT00921856     History of Changes
Other Study ID Numbers: ACOVA-1
Study First Received: June 8, 2009
Last Updated: November 2, 2015

Keywords provided by Robert Bosch Medical Center:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Vasospasm
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Vasodilator Agents
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 26, 2017