The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy) (NCT02767401) | Clinical Trial Compass
CompletedPhase 4
The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
200 participantsStarted 2015-09-15
Plain-language summary
The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on myocardial viability in coronary artery disease patients with single coronary total occlusion (CTO) lesions.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of stable or unstable angina
* LVEF \> 35% on transthoracic echocardiography measurement
* Single lesion occluding the coronary artery detected by angiography or MSCTA, with or without stenosis of other coronary arteries (≤ 50% stenotic lesion)
* Availability for follow-up for up to 12 months
* No major barriers to provide written consent
Exclusion Criteria:
* Acute Q-wave myocardial infarction during the latest 3 months
* Revascularization in the non-culprit artery during the latest one month
* Unsuitable for PCI
* Unable to tolerate dual antiplatelet treatment (DAPT)
* Severe abnormal hematopoietic system, such as platelet count of \< 100×109/L or \> 700×109/L and white blood cell count of \< 3×109/L
* Active bleeding or bleeding tendency
* Severe coexisting conditions, such as severe renal insufficiency (GFR \< 60 ml/min•1.73m2), severe hepatic dysfunction \[elevated ALT (glutamic-pyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
* Life expectancy \< 12 months
* Pregnancy or planning pregnancy
* Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
* Participation or planning to participate in another clinical trial during the same period
* Refusal to comply with the study protocol
What they're measuring
1
Changes to myocardial viability
Timeframe: 12 months
Trial details
NCT IDNCT02767401
SponsorThe First Affiliated Hospital of Dalian Medical University