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Prognostic Value of Endothelial Dysfunction and Coronary Complexity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Seigo Sugiyama, Kumamoto University.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Seigo Sugiyama, Kumamoto University Identifier:
First received: August 18, 2008
Last updated: June 21, 2012
Last verified: June 2012
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.

Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incremental Significance of Endothelial Function Assessed by Reactive Hyperemia Peripheral Arterial Tonometry to Improve Risk Stratification in High Risk Patients for Cardiovascular Events

Further study details as provided by Seigo Sugiyama, Kumamoto University:

Primary Outcome Measures:
  • Cardiovascular event [ Time Frame: Outcome is assessed 1 to 4 years after entry ]
    Cardiovascular event consists of cardiovascular death, myocardial infarction, unstable angina, ischemic stroke, coronary revascularization, hospitalization for heart failure, aortic disease and peripheral arterial disease.

Estimated Enrollment: 500
Study Start Date: August 2006
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Detailed Description:
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).

Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Kumamoto University Hospital and Yokohama City University Medical Center

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00737945

Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seigo Sugiyama, Department of Cardiovascular Medicine, Kumamoto University Identifier: NCT00737945     History of Changes
Other Study ID Numbers: 0804
Study First Received: August 18, 2008
Last Updated: June 21, 2012

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on June 23, 2017