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Prognostic Value of Endothelial Dysfunction and Coronary Complexity

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ClinicalTrials.gov Identifier: NCT00737945
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Seigo Sugiyama, Kumamoto University

Brief Summary:
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 or disease
Cardiovascular Disease

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).

Study Type : Observational
Actual Enrollment : 1000 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Group/Cohort
2



Primary Outcome Measures :
  1. 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.



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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

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

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 Posted: August 20, 2008    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Cardiovascular Diseases