Coronary VasospasmNCT00619294
Endothelial Dysfunction and Coronary Artery Spasm
An observational study of Coronary Vasospasm, run by Kumamoto University at 1 site in Japan.
Trial summary
Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA). CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG). Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Coronary Vasospasm
- How many people
- 158 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2006to May 2009
- Phase
- Observational
- 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 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Kumamoto University Hospital
Who may be able to join
- Stable post-menopausal women complaining angina-like chest pain
Who cannot join
- Severe valvular disease
- Hypertrophic cardiomyopathy
- Severe peripheral artery disease
- Uncontrolled hypertension
- Severe collagen diseases
- Acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Tonometry for Measurement of Peripheral Artery Reactive Hyperemia as Non-invasive Test for Diagnosis of Coronary Artery Spasm
Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA). CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG). Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip RH-PAT could predict the presence of CSA in women.
Read the detailed description
Outline of methods:
RH-PAT was measured in women with chest pain prior to CAG. Coronary spasm was diagnosed by intra-coronary acetylcholine (ACh) provocation test. Using Flow-Wire, we assessed coronary endothelial function by coronary blood flow increase in response to ACh (ACh-CBF) and coronary flow reserve was assessed by adenosine (Ad-CFR).
- Conditions
- Coronary Vasospasm
- Keywords
- Coronary Vasospasm, Endothelium, Vascular, Vasodilation, Hyperemia
- Medical subject headings
- Coronary Vasospasm, Aneurysm, Hyperemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic heart disease diagnosed by cardiac catheterization
Measured: From Aug 2006 to May 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startAug 2006
- Primary completionMay 2009
- Study completionMay 2009
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seigo Sugiyama, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619294
- Sponsor's protocol ID
- 743
- Status last verified
- Sep 2013
- First submitted
- 8 Feb 2008
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsuzawa Y, Sugiyama S, Sugamura K, Nozaki T, Ohba K, Konishi M, Matsubara J, Sumida H, Kaikita K, Kojima S, Nagayoshi Y, Yamamuro M, Izumiya Y, Iwashita S, Matsui K, Jinnouchi H, Kimura K, Umemura S, Ogawa H. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol. 2010 Apr 20;55(16):1688-96. doi: 10.1016/j.jacc.2009.10.073.
PubMed 20394872
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Tonometry for Measurement of Peripheral Artery Reactive Hyperemia as Non-invasive Test for Diagnosis of Coronary Artery Spasm
- ClinicalTrials.gov ID
- NCT00619294
- Acronym / sponsor ID
- 743
- Conditions
- Coronary Vasospasm
- Keywords
- Coronary Vasospasm, Endothelium, Vascular, Vasodilation, Hyperemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Feb 2008 (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.
Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA). CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG). Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip RH-PAT could predict the presence of CSA in women.
Detailed description
Outline of methods:
RH-PAT was measured in women with chest pain prior to CAG. Coronary spasm was diagnosed by intra-coronary acetylcholine (ACh) provocation test. Using Flow-Wire, we assessed coronary endothelial function by coronary blood flow increase in response to ACh (ACh-CBF) and coronary flow reserve was assessed by adenosine (Ad-CFR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kumamoto University Hospital
Key inclusion criteria (1 listed)
- Stable post-menopausal women complaining angina-like chest pain
Key exclusion criteria (6 listed)
- Severe valvular disease
- Hypertrophic cardiomyopathy
- Severe peripheral artery disease
- Uncontrolled hypertension
- Severe collagen diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ischemic heart disease diagnosed by cardiac catheterization
Time frame: From Aug 2006 to May 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
- Derived from this study: PubMed 20394872Matsuzawa Y, Sugiyama S, Sugamura K, Nozaki T, Ohba K, Konishi M, Matsubara J, Sumida H, Kaikita K, Kojima S, Nagayoshi Y, Yamamuro M, Izumiya Y, Iwashita S, Matsui K, Jinnouchi H, Kimura K, Umemura S, Ogawa H. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol. 2010 Apr 20;55(16):1688-96. doi: 10.1016/j.jacc.2009.10.073.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Vasospasm, run by Kumamoto University at 1 site in Japan.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 26 Sep 2013. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic heart disease diagnosed by cardiac catheterization (time frame: From Aug 2006 to May 2009). 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 NCT00619294, 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 26 Sep 2013; AzTrials last refreshed its copy on 28 Oct 2026.