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

Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00921856
Acronym
ACOVA
Enrollment
1000
Registered
2009-06-16
Start date
2007-11-30
Completion date
2025-12-31
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Vasospasm, Microvascular Angina

Keywords

Acetylcholine

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.

Interventions

OTHERIntracoronary 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.

Sponsors

Deutsche Stiftung für Herzforschung
CollaboratorOTHER
Peter Ong, MD
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
all cause mortality (cardiac vs. non-cardiac)12-120 months

Secondary

MeasureTime frame
Angina pectoris, repeated angiography, re-admissions for angina pectoris12-120 months

Countries

Germany

Contacts

Primary ContactPeter Ong, MD
petereong@gmail.com+4971181015449
Backup ContactAndreas Seitz, MD
+4971181015585

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026