Endothelial Dysfunction and Coronary Artery Spasm

NCT ID: NCT00619294

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Coronary Vasospasm

Keywords

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Coronary Vasospasm Endothelium, Vascular Vasodilation Hyperemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kumamoto University

OTHER

Sponsor Role lead

Responsible Party

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Seigo Sugiyama

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Site Status

Countries

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Japan

References

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Matsuzawa Y, Sugiyama S, Sugamura K, Nozaki T, Ohba K, Konishi M, Matsubara J, Sumida H, Kaikita K, Kojima S, Nagayoshi Y, Yamamuro M, Izumiya Y, Iwashita S, Matsui K, Jinnouchi H, Kimura K, Umemura S, Ogawa H. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol. 2010 Apr 20;55(16):1688-96. doi: 10.1016/j.jacc.2009.10.073.

Reference Type DERIVED
PMID: 20394872 (View on PubMed)

Other Identifiers

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743

Identifier Type: -

Identifier Source: org_study_id