Prognostic Value of Endothelial Dysfunction and Coronary Complexity

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
Change History	Complete list of historical versions of study NCT00737945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Removed Location Countries
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