This trial is active, not recruiting.

Condition post myocardial infarction patients with ejection fraction less than or equal to 35%
Treatment external loop recorder
Sponsor Medtronic BRC
Collaborator Medtronic
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
external loop recorder NUVANT Mobile Cardiac Telemetry (MCT) system (CorventisTM)

Primary Outcomes

Clinically significant arrhythmias reported by ELR at acute monitoring period
time frame: 12 months

Secondary Outcomes

Clinically significant arrhythmias reported by ELR
time frame: 8-10 weeks post MI

Eligibility Criteria

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

Additional Information

Official title IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Medtronic BRC.