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Prognostic Value of Endothelial Dysfunction and Coronary Complexity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seigo Sugiyama, Kumamoto University
ClinicalTrials.gov Identifier:
NCT00737945
First received: August 18, 2008
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  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 Kumamoto University:

Primary Outcome Measures:
  • Cardiovascular event [ Time Frame: Outcome is assessed 1 to 4 years after entry ] [ Designated as safety issue: No ]
    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).

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737945

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

No publications provided

Responsible Party: Seigo Sugiyama, Department of Cardiovascular Medicine, Kumamoto University
ClinicalTrials.gov Identifier: NCT00737945     History of Changes
Other Study ID Numbers: 0804
Study First Received: August 18, 2008
Last Updated: June 21, 2012
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013