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

This study is currently recruiting participants.
Verified April 2017 by Peter Ong, MD, Robert Bosch Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921856
First Posted: June 16, 2009
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Ong, MD, Robert Bosch Medical Center
  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: None (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 Peter Ong, MD, 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 2019
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921856


Contacts
Contact: Peter Ong, MD +4971181015449 petereong@gmail.com
Contact: Anastasios Athanasiadis, MD +4971181015444

Locations
Germany
Robert Bosch Medical Center Recruiting
Stuttgart, Germany, 70376
Contact: Peter Ong, MD    +4971181016048    petereong@gmail.com   
Contact: Anastasios Athanasiadis, MD    +4971181015444      
Sponsors and Collaborators
Peter Ong, MD
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Ong, MD, Oberarzt, Robert Bosch Medical Center
ClinicalTrials.gov Identifier: NCT00921856     History of Changes
Other Study ID Numbers: ACOVA-1
First Submitted: June 8, 2009
First Posted: June 16, 2009
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Peter Ong, MD, Robert Bosch Medical Center:
Acetylcholine

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