Prognostic Value of Endothelial Dysfunction and Coronary Complexity

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737945
• Other study ID #: 0804
• Status: Completed
• Phase: N/A
• First received: August 18, 2008
• Last updated: August 23, 2017
• Start date: August 2006
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Japan	Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular event	Cardiovascular event consists of cardiovascular death, myocardial infarction, unstable angina, ischemic stroke, coronary revascularization, hospitalization for heart failure, aortic disease and peripheral arterial disease.	Outcome is assessed 1 to 4 years after entry