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Endothelial Dysfunction and Coronary Artery Spasm
This study is ongoing, but not recruiting participants.
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



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