'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians Presenting With Non-ST-elevation Acute Coronary Syndromes: The MIMOSA Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
研究概览
简要总结
Older patients with co-morbidity are increasingly represented in interventional cardiology practice. They have been historically excluded from studies regarding the optimal management of NSTEACS. Though there are associated risks with invasive treatment, such patients likely derive the greatest absolute benefit from PCI. Small, though highly selective, studies suggest a routine invasive strategy may reduce the risk of recurrent myocardial infarction.
The study aims to include, as far as possible, an 'all-comers' population of patients aged 80 and above to define the optimum amount of revascularization required to achieve good outcomes and satisfactory symptom relief for this challenging cohort of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥80 years
- •Non-ST-elevation acute coronary syndromes, defined as per guidelines:
- •Ischaemic chest pain or equivalent AND either
- •Electrocardiography with persistent or transient ST-depression and/or T-wave inversion OR
- •Biomarker positive for myocardial necrosis
- •Multi-vessel coronary artery disease, defined as the presence of an angiographic >90% diameter or FFR-(<0.81) or iFR-(<0.90) positive stenoses(29) in a non-culprit vessel of reference diameter ≥2.5mm.
排除标准
- •Inability to give written informed consent
- •Resuscitation from cardiac arrest
- •Life expectancy <12 months
- •Cardiogenic shock
- •Ventricular arrhythmias refractory to treatment at the time of randomization
- •Coronary artery disease not amenable to PCI
- •Heart Team decision for coronary bypass surgery
- •Type 2 myocardial infarction(30) or alternative diagnoses such as tako-tsubo cardiomyopathy, as defined by the operator in light of the clinical picture at presentation
- •Estimated glomerular filtration rate (eGFR) <20mL/min/m2 (by Cockcroft-Gault formula)
- •Documented anaphylaxis induced by iodinated contrast media
- •Documented allergies to either aspirin, clopidogrel, ticagrelor or oral anticoagulants
- •Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:
- •Active internal bleeding
- •Bleeding diastheses precluding treatment with dual antiplatelet therapy and/or oral anticoagulation
- •Platelet count <90,000/μL at screening
- •Previous intracranial haemorrhage
- •Clinically significant gastrointestinal bleeding within 12 months before randomization
- •Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening (confirmed with repeat testing): alanine transaminase (ALT) >5 times the upper limit of normal or ALT >3 times the upper limit of normal plus total bilirubin >2 times the upper limit of normal
- •Major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within the past 30 days
- •Any active non-cutaneous malignancy
结局指标
主要结局
Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
时间窗: 12 months
Components of composite endpoint as defined below.
次要结局
- EQ-5D-5L quality of life assessment(12 months)
- Incidence of Urgent unplanned revascularization(12 months)
- Incidence of Cardiac death(12 months)
- Incidence of Myocardial infarction(12 months)
- Incidence of TIMI major and minor bleeding(12 months)
- Seattle Angina Questionnaire score(12 months)
- Incidence of Stroke(12 months)
- Incidence of contrast-induced nephropathy after PCI(72 hours after PCI)
研究者
Francis Joshi
Principal Investigator, Interventional Cardiologist
Rigshospitalet, Denmark