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Prognostic Value of Endothelial Dysfunction and Coronary Complexity
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Seigo Sugiyama, Kumamoto University.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Kumamoto University
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
| 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 |
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. |
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| 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 |
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| 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 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. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Unknown status | ||
| 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Seigo Sugiyama, Kumamoto University | ||
| Study Sponsor ICMJE | Kumamoto University | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Kumamoto University | ||
| Verification Date | June 2012 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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