Clinical trial NCT00921856: Abnormal Coronary Vasomotion in Patients With Suspected Coronary Artery Disease (CAD)
Official title: Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Vasospasm
Microvascular Angina
Coronary Artery Disease
Keywords: Acetylcholine
Lead sponsor: Robert Bosch Medical Center
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für Herzforschung
First posted: 2009-06-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: all cause mortality (cardiac vs. non-cardiac)
timeFrame: 12-120 months
Secondary outcomes:
measure: Angina pectoris, repeated angiography, re-admissions for angina pectoris
timeFrame: 12-120 months
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Medical Center
Study officials:
affiliation: Robert Bosch Medical Center
name: Peter Ong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Bosch Medical Center
name: Andreas Seitz, MD
role: STUDY_CHAIR
affiliation: Robert Bosch Medical Center
name: Udo Sechtem, MD
role: STUDY_DIRECTOR
References:
citation: 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.