PREDICTing long-term clinical outcomes by Optical coherence tomography assessment of plaque characteristics in the non-Revascularized coronary artery
- Conditions
- Ischemic heart disease
- Registration Number
- JPRN-UMIN000031937
- Lead Sponsor
- Kokura Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 200
Not provided
1.Subject with left main lesion. 2.Subject with a history of coronary artery bypass grafting. 3.Known renal insufficiency (estimated serum creatinine clearance <30ml/min or maintenance hemodialysis). 4.Severe angulation (>90 degrees) or excessive tortuosity (>two 45 degrees angles) not suitable for OCT assessments. 5.Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy 6.Life expectancy less than 1 year. 7.Known allergy against protocol-required medications including aspirin, prasugrel, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated). 8.Cardiogenic shock or decompensate heart failure requiring intubation, vasopressors, and hemodynamic support (IABP and/or PCPS). 9.History of bleeding diathesis or known coagulopathy. 10.Planned surgery within the next 12 months
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method