Endothelial Dysfunction and Coronary Artery Spasm - Full Text View

Sponsored by:	Kumamoto University
Information provided by:	Kumamoto University
ClinicalTrials.gov Identifier:	NCT00619294

Purpose

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.

Condition
Coronary Vasospasm

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Digital Tonometry for Measurement of Peripheral Artery Reactive Hyperemia as Non-Invasive Test for Diagnosis of Coronary Artery Spasm

Further study details as provided by Kumamoto University:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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).

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Kumamoto University Hospital

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619294

Locations

Japan
Kumamoto University Hospital
Kumamoto, Japan, 860-8556

Sponsors and Collaborators

Kumamoto University

More Information

Responsible Party:	Department of Cardiovascular Medicine, Kumamoto University ( Seigo Sugiyama )
Study ID Numbers:	743
Study First Received:	February 8, 2008
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00619294
Health Authority:	Japan: Institutional Review Board

Keywords provided by Kumamoto University:

Coronary Vasospasm
Endothelium, Vascular
Vasodilation
Hyperemia

Study placed in the following topic categories:

Coronary Disease
Spasm
Hyperemia
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Coronary Vasospasm
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009