Coronary VasospasmACOVANCT00921856
Abnormal Coronary Vasomotion in Patients With Suspected Coronary Artery Disease (CAD)
A study testing Intracoronary acetylcholine provocation test in people with Coronary Vasospasm and Microvascular Angina, run by Peter Ong, MD at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Coronary Vasospasm, Microvascular Angina, Coronary Artery Disease
- What is being tested?
- Intracoronary acetylcholine provocation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Patients under 35 years and above 95 years of age
- Severe chronic obstructive pulmonary disease (contraindication for acetylcholine-testing)
Trial locations and contacts
1 site in 1 country.
Andreas Seitz, MD contact
Germany1 site, 1 recruiting
- Recruiting
Robert Bosch Medical Center
Stuttgart, 70376
Peter Ong, MD, +4971181016048, petereong@gmail.com
Anastasios Athanasiadis, MD, +4971181015444
About this study
Official title: Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries
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.
- Being tested
- Intracoronary acetylcholine provocation test
- Keywords
- Acetylcholine
- Medical subject headings
- Coronary Vasospasm, Microvascular Angina, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary acetylcholine provocation testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CAD | No intervention | Patients admitted with suspicion of CAD and proof of CAD after coronary angiography. |
| No-CAD | Experimental | Patients admitted with suspicion of CAD but without proof of CAD after coronary angiography will undergo intracoronary acetylcholine provocation test. Receives: Other: Intracoronary acetylcholine provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality (cardiac vs. non-cardiac)
Measured: 12-120 months
Secondary outcomes (1)
Angina pectoris, repeated angiography, re-admissions for angina pectoris
Measured: 12-120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary VasospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Ong, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Responsible party
- Sponsor-investigator, Peter Ong, MD, Robert Bosch Medical Center
- Investigators
- Peter Ong, MD, Principal investigator, Robert Bosch Medical CenterAndreas Seitz, MD, Study chair, Robert Bosch Medical CenterUdo Sechtem, MD, Study director, Robert Bosch Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921856
- Sponsor's protocol ID
- ACOVA-1
- Other IDs
- ACOVA-2
- Acronym
- ACOVA
- Status last verified
- May 2023
- First submitted
- 8 Jun 2009
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22322081
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries
- ClinicalTrials.gov ID
- NCT00921856
- Acronym / sponsor ID
- ACOVA / ACOVA-1
- Keywords
- Acetylcholine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peter Ong, MDUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Study start
- Nov 2007
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD | No intervention | –Patients admitted with suspicion of CAD and proof of CAD after coronary angiography. |
| No-CAD | Experimental | Other: Intracoronary acetylcholine provocation testPatients admitted with suspicion of CAD but without proof of CAD after coronary angiography will undergo intracoronary acetylcholine provocation test. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (2 listed)
- Patients under 35 years and above 95 years of age
- Severe chronic obstructive pulmonary disease (contraindication for acetylcholine-testing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracoronary acetylcholine provocation testIntracoronary 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. | Other | No-CAD |
Primary outcome
all cause mortality (cardiac vs. non-cardiac)
Time frame: 12-120 months
1 secondary outcome
Angina pectoris, repeated angiography, re-admissions for angina pectoris
Time frame: 12-120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 22322081Ong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Seitz, MD contact
Peter Ong, MD principal investigator
Robert Bosch Medical Center
Andreas Seitz, MD study chair
Robert Bosch Medical Center
Udo Sechtem, MD study director
Robert Bosch Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracoronary acetylcholine provocation test in people with Coronary Vasospasm and Microvascular Angina, run by Peter Ong, MD at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Ong, MD (+4971181015449, petereong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (cardiac vs. non-cardiac) (time frame: 12-120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00921856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.