Study to identify patients with High risk after acute MI using a wearable detection system. (External Loop Recorder)

Phase 4

Conditions: Health Condition 1: null- The study will enroll acute post MI patients with a reduced LVEF (â?¤35%) one day before or on the day of discharge from hospital after index MI. There is no control group in this study

Registration Number: CTRI/2013/12/004216

Lead Sponsor: India Medtronic Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

•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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â??Clinically significant arrhythmias reported by ELR at acute monitoring periodTimepoint: No specific Time point

Secondary Outcome Measures

Name	Time	Method
â??Clinically significant arrhythmias reported by ELR at chronic (8-10 weeks post MI) monitoring period <br/ ><br>â??ELR reported arrhythmia driven medical interventions or needs for medical interventions <br/ ><br>â??All-cause mortality <br/ ><br>â??Sudden cardiac death or resuscitated Ventricular Fibrillation or appropriate shockTimepoint: No specific Timepoint