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OpenTrials
Completed

NCT Number: NCT00619294

Endothelial Dysfunction and 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.

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Key information

Conditions

Coronary Vasospasm Aneurysm Cardiovascular Diseases Coronary Disease Heart Diseases Hyperemia Myocardial Ischemia Vascular Diseases

Age range

40 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ischemic heart disease diagnosed by cardiac catheterization

    Time frame: From Aug 2006 to May 2009

Sponsors and collaborators

Lead sponsor

Kumamoto University

Other

Registry information

Official study title

Digital Tonometry for Measurement of Peripheral Artery Reactive Hyperemia as Non-invasive Test for Diagnosis of Coronary Artery Spasm

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 20, 2008
Registry last updated
Sep 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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