Prognostic Value of Endothelial Dysfunction and Coronary Complexity

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2012 by Kumamoto University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Seigo Sugiyama, Kumamoto University

ClinicalTrials.gov Identifier:

NCT00737945

First received: August 18, 2008

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 18, 2008
Last Updated Date	June 21, 2012
Start Date ^ICMJE	August 2006
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 21, 2012)	Cardiovascular event [ Time Frame: Outcome is assessed 1 to 4 years after entry ] [ Designated as safety issue: No ] 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 ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00737945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prognostic Value of Endothelial Dysfunction and Coronary Complexity
Official Title ^ICMJE	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 ^ICMJE	Observational
Study Design ^ICMJE	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 ^ICMJE	Cardiovascular Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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 ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	500
Estimated Completion Date	August 2012
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years to 90 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Japan
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00737945
Other Study ID Numbers ^ICMJE	0804
Has Data Monitoring Committee	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Seigo Sugiyama, Kumamoto University
Study Sponsor ^ICMJE	Kumamoto University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kumamoto University
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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