This trial is active, not recruiting.

Condition cardiovascular disease
Sponsor Kumamoto University
Start date August 2006
End date August 2012
Trial size 500 participants
Trial identifier NCT00737945, 0804


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Cardiovascular event
time frame: Outcome is assessed 1 to 4 years after entry

Eligibility Criteria

Male or female participants from 30 years up to 90 years old.

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

Additional Information

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
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Kumamoto University.