Routine Invasive Vs Ischemia Driven Strategy In Patients With ST-Segment-Elevation Myocardial Infarction Presenting Between 12-72 Hours Of Symptom Onset (LATECOMER TRIAL)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,890
- 试验地点
- 12
- 主要终点
- Composite endpoint of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization
研究概览
简要总结
a) Gaps in existing knowledge: The benefit of early invasive strategy in STEMI patients presenting late after conventional myocardial salvage period of 12 hours but before 48 hours of symptom onset is controversial and unexplored.
b) Novelty: The proposed trial will be the first study to assess the effect of early invasive strategy based on PCI with stenting in STEMI patients presenting late i.e., 12-48 hours of symptom onset and without any symptom suggestive of ongoing ischemia, hemodynamic instability, refractory angina. The study has been designed to include a large sample size to obtain a definite conclusion with adequate power.
c) Objective: The primary objective will be to assess the role of early invasive strategy in reducing a composite endpoint of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization compared with a conservative ischemia driven strategy.
d) Methods: The study will be a multicentre, prospective, parallel-group, open-level randomized control trial. All STEMI patients presenting late to emergency department of the participating centres within 12- 48 hours of symptom onset without any revascularization by thrombolysis or primary PCI after satisfying eligibility criteria will be randomized in a 1:1 ratio to the ‘early invasive therapy’ or ‘conservative ischemia driven strategy’ arms. All patients will be assessed for average two years for the composite outcome.
e) Expected outcome: We expect that early invasive strategy will result in significant benefits in terms of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization in STEMI patients presenting 12-48 hours after pain onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age greater than or equals to 18 years, less than or equals to 80 years Patients having ST-segment elevation myocardial infarction (STEMI) which is defined as at least one episode of angina or angina equivalent lasting for greater than or equals to 30 minutes and supportive ECG changes as follows –.
- •ST-segment elevation (measured at the J-point): in at least two contiguous leads with ST-segment elevation greater than or equals to 2.5 mm in men less than 40 years, greater than or equals to 2 mm in men less than 40years, or greater than or equals to 1.5mm in women in leads V2–V3 and/or greater than or equals to 1mm in the other leads [in the absence of left ventricular (LV) hypertrophy or left bundle branch block LBBB)]. In the presence of LBBB, presence of concordant ST elevation greater than or equals to 1 mm in greater than or equals to 1 lead/ concordant ST depression greater than or equals to 1 mm in greater than or equals to 1 lead of V1-V3/ proportionally excessive discordant STE in greater than or equals to 1 lead anywhere with less than or equals to 1 mm STE, as defined by greater than or equals to 25% of the depth of the preceding S-wave (Smith-modified Sgarbossa Criteria) New Q-waves of greater than or equals to 0.03 sec and or 1by3 of QRS complex in greater than or equals to 2 related EKG leads. Patient presenting greater than 12 hours, but less than 72 hours of symptom onset. Not revascularized by either thrombolysis or PCI.
排除标准
- •Clinical indications of revascularization: symptom suggestive of ongoing ischemia, hemodynamic instability (Systolic blood pressure less than 90 mmHg, unresponsive to fluids, or requiring ionotropic support), refractory angina, severe congestive heart failure and/or pulmonary edema, complete heart block, refractory arrhythmia.
- •Patients presenting with mechanical complications of STEMI – ventricular septal rupture, ventricular free wall rupture, acute severe mitral regurgitation due to papillary muscle rupture.
- •Other serious illnesses with poor life expectancy like – malignancy, severe pulmonary disease, severe liver disease iv.
- •Severe renal dysfunction with serum creatinine greater than or equals to 2 mg/dl that may increase the risk of contrast nephropathy.
- •Patient who had prior CABG and qualifying infarct-related artery has been grafted previously.
- •Severe valvular heart disease vii.
- •History of allergy or anaphylaxis with contrast agents.
- •Pregnancy ix.
- •Contraindication to antiplatelet therapy x.
- •Active bleeding or bleeding diatheses xi.
- •Recent trauma or major surgery (during the last month); Relevant hematologic deviations (hemoglobin less than 10 g/dL or hematocrit 34%, platelet cell count of less than 100 x 103/μL, white blood cell count less than 3 x 103/μL).
- •Recent PCI (within the last 30 days) xiii.
- •Previous stroke (within the last 3 months) xiv.
- •Known case of hypertrophic or restrictive cardiomyopathy xv.
- •Inability to cooperate with protocol and long term follow up Refusal or inability to give informed consent.
结局指标
主要结局
Composite endpoint of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization
时间窗: Outcome will be assessed at Baseline, 4th Month, 8th Month, 12th Month, 16th Month, 20th Month and 24th Month.
次要结局
- all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization, Health-related quality of life, Change in left ventricular ejection fraction, A composite of the first to occur of death, recurrent MI, heart failure hospitalization, sustained ventricular arrhythmia, automatic implantable cardiac defibrillator (AICD) placement, or stroke.(Outcome will be assessed at Baseline, 4th Month, 8th Month, 12th Month, 16th Month, 20th Month & 24th Month.)
研究者
Dr S Ramakrishnan
AIIMS New Delhi