The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Changes to myocardial viability
研究概览
简要总结
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.
详细描述
Patients with coronary artery disease might benefit from successful percutaneous coronary intervention (PCI). However, there is currently no consensus on an optimal treatment modality for single lesions resulting in coronary total occlusion (CTO). Since the other coronary arteries are often lesion-free, or with stenosis of less than 50%, patients often present with no symptoms. Although the expert consensus on CTO lesion suggests reducing the incidence of long-term adverse events via successful revascularization, there are few retrospective studies on single CTO lesions. To date, it is unclear whether successful PCI based on optimal medication treatment (OMT) can increase myocardial viability and the extent of myocardial viability related to prognosis of those CTO patients. Therefore, the aim of this multi-center, prospective, open labeled, non-randomized controlled study was to determine if the improvement to myocardial viability in single CTO patients with successful PCI plus OMT was superior to that of patients with only OMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PCI using stenting or balloon expansion
Opening single CTO lesions using drug-eluting stents (such as Xience V and Prime, Endeavor Resolute, Taxus express and Libete, Excel, Partner, BUMA, YINYI, TIVOLI,Firebird2,FireHawk, and Coroflex) or balloon expansion plus optimal medical therapy. Intravascular ultrasound (IVUS),optimal coherence tomgraphy (OCT) or fractional flow reserve (FFR) is used if they are needed. Optimal medical therapy includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-angina therapy should be used if the patients have symptoms.
干预措施: stenting or balloon expansion (Device)
PCI using stenting or balloon expansion
Opening single CTO lesions using drug-eluting stents (such as Xience V and Prime, Endeavor Resolute, Taxus express and Libete, Excel, Partner, BUMA, YINYI, TIVOLI,Firebird2,FireHawk, and Coroflex) or balloon expansion plus optimal medical therapy. Intravascular ultrasound (IVUS),optimal coherence tomgraphy (OCT) or fractional flow reserve (FFR) is used if they are needed. Optimal medical therapy includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-angina therapy should be used if the patients have symptoms.
干预措施: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc (Drug)
结局指标
主要结局
Changes to myocardial viability
时间窗: 12 months
Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system
次要结局
- Major adverse cardiac events(12 months)
- The rates of target vascular revascularization (TVR), TLR, and stent thrombosis(12 months)
- Changes to left ventricular ejection fraction (LVEF)(12 months)
- Changes to myocardial infarct size(12 months)
- Changes to left ventricular mass (LVM)(12 months)
- Changes to cardiac output (CO)(12 months)
- Changes to stroke volume (SV)(12 months)
- Changes to maximum left ventricular ejection rate(12 months)
- Changes to maximum left ventricular filling rate(12 months)
- Changes to maximum slope(12 months)
- Changes to left ventricular end-diastolic diameter (LVEDd)(12 months)
- Changes to left ventricular end-systolic diameter (LVESd)(12 months)
- Changes to cardiac systolic function(12 months)