Endothelial Dysfunction and Coronary Artery Spasm

Coronary Vasospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619294
• Other study ID #: 743
• Status: Completed
• Phase: N/A
• First received: February 8, 2008
• Last updated: September 25, 2013
• Start date: August 2006
• Est. completion date: May 2009

Study information

• Verified date: September 2013
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Vasospasm

Locations

Country	Name	City	State
Japan	Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic heart disease diagnosed by cardiac catheterization		From Aug 2006 to May 2009	No