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OpenTrials
Completed

NCT Number: NCT00737945

Prognostic Value of Endothelial Dysfunction and Coronary Complexity

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kumamoto University

Other

Registry information

Official study title

Incremental Significance of Endothelial Function Assessed by Reactive Hyperemia Peripheral Arterial Tonometry to Improve Risk Stratification in High Risk Patients for Cardiovascular Events

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Aug 20, 2008
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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