IdeNtifying High riSk Patients Post Myocardial Infarction with REduced Left Ventricular Function using External Loop Recorders - INSPIRE-ELR

India Medtronic Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients must provide written informed consent/data release consent to participate in the study.
•2.Acute Myocardial Infarction (STEMI or non-STEMI) within the last 10 days based on ESC/ACC/AHA/WHF criteria (Thygesen, 2012) matching the following criteria:
•Rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
•a.Symptoms of ischaemia.
•b.New or presumed new significant ST-segmentâ??T wave (STâ??T) changes or new left bundle branch block (LBBB).
•c.Development of pathological Q waves in the ECG.
•d.Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
•e.Identification of an intracoronary thrombus by angiography.
•3.LVEF <=35% as measured by echocardiography (Simpsonâ??s method, biplane) one day before or on the day of hospital discharge

•Patients who cannot be discharged from the hospital within14 days after index Myocardial Infarction event
•Age 18 years
•Psychologically incapacitated
•Patient is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
•Patients contraindicated for NUVANT system
•Comorbidities likely to limit survival to less than the minimal study duration (12 months)
•Participation in an investigational study with known or suspected cardiac effect expected to confound the results of this study (e.g. stem cell trials, stent trials, cardiac intervention trials, drug trials)
•Patients with an existing pacemaker or ICD implanted.
•Patients that are dialysis dependent at discharge

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