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PREDICTing long-term clinical outcomes by Optical coherence tomography assessment of plaque characteristics in the non-Revascularized coronary artery

Not Applicable
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
Inclusion Criteria

Not provided

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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