IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
This trial is active, not recruiting.
|Condition||post myocardial infarction patients with ejection fraction less than or equal to 35%|
|Treatment||external loop recorder|
|Start date||April 2014|
|End date||February 2017|
|Trial size||250 participants|
|Trial identifier||NCT01995552, REF/2013/10/005823, Version 3.0 , 22 Apr 2015|
The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%) patients in the acute phase (at discharge from hospital after index MI) and chronic phase (at 8-10 weeks after index MI) and to correlate with patients at high risk of all-cause mortality or sudden cardiac death (SCD) at 1 year.
|Intervention model||single group assignment|
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
Clinically significant arrhythmias reported by ELR at acute monitoring period
time frame: 12 months
Clinically significant arrhythmias reported by ELR
time frame: 8-10 weeks post MI
Male or female participants at least 18 years old.
Patients must meet all of the below criteria to be eligible for the study: - Patients must provide written informed consent/data release consent to - participate in the study. - Acute Myocardial Infarction (STEMI or non-STEMI) documented within 10 days of onset, matching one of the following criteria: - Acute ST segment elevation greater than or equal to 0.1 mv on ECG in 2 or more leads or new LBBB, with symptoms of ischemia - In all other situations, including non ST segment elevation MI, at least one cardiac biomarker value [preferably cardiac troponin (cTn)] above the 99th percentile of a normal reference population (upper reference limit (URL)) AND with at least one of the following (1) new or presumed new ST-T changes (2) Symptoms or signs of Ischemia (3) Development of pathological Q waves in the ECG (4) Identification of an intracoronary thrombus by angiography - LVEF less than or equal to 35 percent as measured by echocardiography Simpsons 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 less than 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
|Official title||IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)|
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