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

August 18, 2008
June 21, 2012
August 2006
August 2012   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00737945 on ClinicalTrials.gov Archive Site
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Prognostic Value of Endothelial Dysfunction and Coronary Complexity
Incremental Significance of Endothelial Function Assessed by Reactive Hyperemia Peripheral Arterial Tonometry to Improve Risk Stratification in High Risk Patients for Cardiovascular Events

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Kumamoto University Hospital and Yokohama City University Medical Center

Cardiovascular Disease
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2
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.
 
Active, not recruiting
500
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00737945
0804
No
Seigo Sugiyama, Kumamoto University
Kumamoto University
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Kumamoto University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP