CTRI/2013/12/004216
Active, Not Recruiting
Phase 4
IdeNtifying High riSk Patients Post Myocardial Infarction with REduced Left Ventricular Function using External Loop Recorders - INSPIRE-ELR
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- 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
- Sponsor
- India Medtronic Pvt Ltd
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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