NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000530

Registered date:27/11/2006

A Randomized Investigation of Short-term Prognosis and Costs and Long-term Prognosis of Medical vs. Coronary Intervention for Low-risk Stable Effort Angina

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedlow-risk stable effort angina
Date of first enrollment2002/02/01
Target sample size400
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)medical therapy as the initial treatment coronary intervention as the initial treatment

Outcome(s)

Primary Outcomedeath (total death, cardiac death, sudden death), acute coronary syndrome (Q-wave infarction, non-Q wave infarction, unstable angina pectoris), and cerebrovascular diseases such as cerebral infarction and cerebral hemorrhage
Secondary Outcomeangina pectoris classification and evaluation of survival

Key inclusion & exclusion criteria

Age minimum30years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) Lesions in LMT or at the ostial site of LAD (within 5 mm from bifurcation) 2) 3-vessel disease 3) 2-vessel chronic total obstruction 4) 1-vessel chronic complete obstruction for which the possibility of PCI success is low (long-term chronic complete obstruction, long complete obstruction lesions) 5) Acute myocardial infarction 6) Ejection fraction of left ventricle less than 50% 7) Lesions not indicated for PCI/CABG (thin lateral branches, peripheral branches) 8) Complications such as bleeding tendency, DIC, and severe pneumonia 9) Impaired renal function (Cr > 1.5 mg/dl) 10) Patients with severe ASO and aneurysms not indicated for PCI/CABG 11) Patients with asymptomatic myocardial ischemia not complicated by effort angina pectoris 12) Patients with unstable angina pectoris who newly developed symptoms or showed aggravation within 6 weeks 13) CABG patients with graft stenosis as a responsible lesion

Related Information

Contact

public contact
Name Kazuhiko Nishigaki, MD
Address Yanagido 1-1, Gifu City, Gifu, JAPAN Japan
Telephone 058-230-6523
E-mail nissy@gifu-u.ac.jp
Affiliation Gifu University Graduate School of Medicine Second Department of Internal Medicine
scientific contact
Name Hisayoshi Fujiwara, MD
Address Yanagido 1-1, Gifu City, Gifu, JAPAN Japan
Telephone 058-230-6523
E-mail
Affiliation Gifu University Graduate School of Medicine Second Department of Internal Medicine