Prognostic Value of Endothelial Dysfunction and Coronary Complexity

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

Tracking Information

• First Submitted Date: August 18, 2008
• First Posted Date: August 20, 2008
• Last Update Posted Date: August 24, 2017
• Study Start Date: August 2006
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2012)

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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prognostic Value of Endothelial Dysfunction and Coronary Complexity
• 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
• 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.
• 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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Kumamoto University Hospital and Yokohama City University Medical Center
• Condition: Cardiovascular Disease
• Intervention: Not Provided
• Study Groups/Cohorts: 2
• Publications *: Matsuzawa Y, Sugiyama S, Sumida H, Sugamura K, Nozaki T, Ohba K, Matsubara J, Kurokawa H, Fujisue K, Konishi M, Akiyama E, Suzuki H, Nagayoshi Y, Yamamuro M, Sakamoto K, Iwashita S, Jinnouchi H, Taguri M, Morita S, Matsui K, Kimura K, Umemura S, Ogawa H. Peripheral endothelial function and cardiovascular events in high-risk patients. J Am Heart Assoc. 2013 Nov 25;2(6):e000426. doi: 10.1161/JAHA.113.000426.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 23, 2017): 1000
• Original Estimated Enrollment (submitted: August 19, 2008): 250
• Actual Study Completion Date: March 2017
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00737945
• Other Study ID Numbers: 0804
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Seigo Sugiyama, Kumamoto University
• Study Sponsor: Kumamoto University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kumamoto University
• Verification Date: August 2017