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Prognostic Value of Endothelial Dysfunction and Coronary Complexity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737945
First Posted: August 20, 2008
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seigo Sugiyama, Kumamoto University
  Purpose
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.

Condition
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.


Enrollment: 1000
Study Start Date: August 2006
Study Completion Date: March 2017
Primary Completion Date: March 2017 (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).
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737945


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seigo Sugiyama, Department of Cardiovascular Medicine, Kumamoto University
ClinicalTrials.gov Identifier: NCT00737945     History of Changes
Other Study ID Numbers: 0804
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Cardiovascular Diseases