Prognostic Value of Endothelial Dysfunction and Coronary Complexity

NCT ID: NCT00737945

Last Updated: 2017-08-24

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2017-03-31

Brief Summary

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The investigators test the additional clinical value of the physiological assessment of endothelial function to the morphological assessment of coronary complexity and classical risk score in predicting cardiovascular events.

Detailed Description

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The investigators enroll consecutive, stable high risk patients for cardiovascular events. The reactive hyperemia peripheral arterial tonometry index (RHI) was measured before coronary angiography and coronary lesions were assessed angiographically by SYNTAX Scoring system. The investigators all subjects and examined the occurrence of cardiovascular events (CV death, non-fatal myocardial infarction and ischemic stroke, unstable angina pectoris, hospitalization for HF, coronary revascularization, or non-fatal aortic and peripheral vascular disease).

Conditions

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Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Stable, high-risk patients with diabetes mellitus, or more than two conventional coronary risk factors, who are referred for coronary angiography because of angina-like chest symptoms.

Exclusion Criteria

* An ejection fraction \< 50%
* Moderate to severe valvular heart disease
* Cardiomyopathy
* Allergy to latex
* Significant endocrine, hepatic, renal, or inflammatory disease
* cerebrovascular disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kumamoto University

OTHER

Sponsor Role lead

Responsible Party

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Seigo Sugiyama

Department of Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Countries

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Japan

References

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Matsuzawa Y, Sugiyama S, Sumida H, Sugamura K, Nozaki T, Ohba K, Matsubara J, Kurokawa H, Fujisue K, Konishi M, Akiyama E, Suzuki H, Nagayoshi Y, Yamamuro M, Sakamoto K, Iwashita S, Jinnouchi H, Taguri M, Morita S, Matsui K, Kimura K, Umemura S, Ogawa H. Peripheral endothelial function and cardiovascular events in high-risk patients. J Am Heart Assoc. 2013 Nov 25;2(6):e000426. doi: 10.1161/JAHA.113.000426.

Reference Type DERIVED
PMID: 24275629 (View on PubMed)

Other Identifiers

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0804

Identifier Type: -

Identifier Source: org_study_id

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