- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619294
Endothelial Dysfunction and Coronary Artery Spasm
September 25, 2013 updated by: Seigo Sugiyama, Kumamoto University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
158
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kumamoto, Japan, 860-8556
- Kumamoto University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Kumamoto University Hospital
Description
Inclusion Criteria:
- Stable post-menopausal women complaining angina-like chest pain
Exclusion Criteria:
- Severe valvular disease
- Hypertrophic cardiomyopathy
- Severe peripheral artery disease
- Uncontrolled hypertension
- Severe collagen diseases
- Acute coronary syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ischemic heart disease diagnosed by cardiac catheterization
Time Frame: From Aug 2006 to May 2009
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From Aug 2006 to May 2009
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
February 8, 2008
First Submitted That Met QC Criteria
February 8, 2008
First Posted (Estimate)
February 20, 2008
Study Record Updates
Last Update Posted (Estimate)
September 26, 2013
Last Update Submitted That Met QC Criteria
September 25, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 743
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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