The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)

• Status: Completed
• Trial end date: 2018-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University
• Collaborators: Beijing Anzhen Hospital; First Hospital of China Medical University; Nanfang Hospital of Southern Medical University
• Treatments: Aspirin; Atorvastatin; Atorvastatin Calcium; Calcium Channel Blockers; Clopidogrel; Metoprolol; Rosuvastatin Calcium; Ticagrelor

Criteria

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