search
Back to results

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

Primary Purpose

Coronary Vasospasm, Microvascular Angina, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intracoronary acetylcholine provocation test
Sponsored by
Peter Ong, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Vasospasm focused on measuring Acetylcholine

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Robert Bosch Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

CAD

No-CAD

Arm Description

Patients admitted with suspicion of CAD and proof of CAD after coronary angiography.

Patients admitted with suspicion of CAD but without proof of CAD after coronary angiography will undergo intracoronary acetylcholine provocation test.

Outcomes

Primary Outcome Measures

all cause mortality (cardiac vs. non-cardiac)

Secondary Outcome Measures

Angina pectoris, repeated angiography, re-admissions for angina pectoris

Full Information

First Posted
June 8, 2009
Last Updated
May 26, 2023
Sponsor
Peter Ong, MD
Collaborators
Deutsche Stiftung für Herzforschung
search

1. Study Identification

Unique Protocol Identification Number
NCT00921856
Brief Title
Abnormal Coronary Vasomotion in Patients With Suspected Coronary Artery Disease (CAD)
Acronym
ACOVA
Official Title
Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Ong, MD
Collaborators
Deutsche Stiftung für Herzforschung

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Vasospasm, Microvascular Angina, Coronary Artery Disease
Keywords
Acetylcholine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAD
Arm Type
No Intervention
Arm Description
Patients admitted with suspicion of CAD and proof of CAD after coronary angiography.
Arm Title
No-CAD
Arm Type
Experimental
Arm Description
Patients admitted with suspicion of CAD but without proof of CAD after coronary angiography will undergo intracoronary acetylcholine provocation test.
Intervention Type
Other
Intervention Name(s)
Intracoronary acetylcholine provocation test
Intervention Description
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.
Primary Outcome Measure Information:
Title
all cause mortality (cardiac vs. non-cardiac)
Time Frame
12-120 months
Secondary Outcome Measure Information:
Title
Angina pectoris, repeated angiography, re-admissions for angina pectoris
Time Frame
12-120 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Ong, MD
Phone
+4971181015449
Email
petereong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Seitz, MD
Phone
+4971181015585
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ong, MD
Organizational Affiliation
Robert Bosch Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Seitz, MD
Organizational Affiliation
Robert Bosch Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Udo Sechtem, MD
Organizational Affiliation
Robert Bosch Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Robert Bosch Medical Center
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Ong, MD
Phone
+4971181016048
Email
petereong@gmail.com
First Name & Middle Initial & Last Name & Degree
Anastasios Athanasiadis, MD
Phone
+4971181015444

12. IPD Sharing Statement

Citations:
PubMed Identifier
22322081
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs