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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Robert Bosch Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Robert Bosch Medical Center
ClinicalTrials.gov Identifier:
NCT00921856
First received: June 8, 2009
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angina pectoris, repeated angiography, re-admissions for angina pectoris [ Time Frame: 12-36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: November 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: April 2011 (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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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 ClinicalTrials.gov identifier: NCT00921856

Contacts
Contact: Peter Ong, MD +447745624863 petereong@gmail.com
Contact: Anastasios Athanasiadis, MD +4971181015444

Locations
Germany
Robert Bosch Medical Center Recruiting
Stuttgart, Germany, 70376
Contact: Peter Ong, MD    +447745624863    petereong@gmail.com   
Contact: Anastasios Athanasiadis, MD    +4971181015444      
Sponsors and Collaborators
Robert Bosch Medical Center
Investigators
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

No publications provided

Responsible Party: Peter Ong, MD, Robert Bosch Medical Center
ClinicalTrials.gov Identifier: NCT00921856     History of Changes
Other Study ID Numbers: ACOVA-1
Study First Received: June 8, 2009
Last Updated: February 22, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Robert Bosch Medical Center:
Acetylcholine

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Coronary Vasospasm
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Acetylcholine
Cardiovascular Agents
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014