Skip to content

A multicenter study of clinical usefulness of flow-mediated vasodilation A

A multicenter study of clinical usefulness of flow-mediated vasodilation A - FMD-J multicenter study A

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000012950
Enrollment
642
Registered
2014-01-24
Start date
2010-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with coronary artery disease

Interventions

None listed

Sponsors

FMD Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Enrolled patients are those with diagnosis of coronary artery disease, with the number of diseased arteries determined by either coronary angiography, cardiac nuclear scintigraphy, or coronary CT and who have been under regular follow-up at any of the participating centers for at least 6 months.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactYukihito Higashi

Research Institute for Radiation Biology and Medicine Department of Cardiovascular Regeneration and Medicine

yhigashi@hiroshima-u.ac.jp082-257-5831

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026