A multicenter study of clinical usefulness of flow-mediated vasodilation A
Not Applicable
Recruiting
- Conditions
- Patients with coronary artery disease
- Registration Number
- JPRN-UMIN000012950
- Lead Sponsor
- FMD Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 642
Inclusion Criteria
Not provided
Exclusion Criteria
A history of coronary bypass surgery; severe valvular heart disease; arrhythmia which requires treatment (ie, atrial fibrillation, atrial flutter, permanent pacemaker implantation or frequent ventricular premature beats); severe chronic heart failure (a New York Heart Association level of greater than Level III); malignancy; current receiving treatment with steroids, nonsteroidal anti-inflammatory drugs or immunosuppressive drugs; a serum creatinine level greater than 2.5 mg/dL; a history of stroke or aortic disease, and serious liver disease.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The present study has 2 primary composite endpoints; the first was coronary artery restenosis or de novo coronary artery stenosis as confirmed by diagnostic imaging (ie, coronary angiography, coronary computed tomography, or radioisotope scintigraphy) either with or without the clinical symptoms of fatal or nonfatal myocardial infarction; second was stroke or heart failure and sudden death.
- Secondary Outcome Measures
Name Time Method The secondary endpoints include each of the 2 primary endpoints plus recurrence of angina pectoris without confirmation by diagnostic imaging (ie, confirmed by symptom self-reports only), newly diagnosed aortic diseases (aneurysm or dissection) as confirmed by diagnostic imaging, newly diagnosed peripheral arterial disease as confirmed by an ABI of less than 0.9, and malignancy or death.