Working… Menu

IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study) (INSPIRE-ELR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01995552
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Information provided by (Responsible Party):
Medtronic BRC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post MI Left Ventricular Dysfunction Device: External Loop Recorder Not Applicable

Detailed Description:
The study is a prospective, multi-center, interventional, non-randomized study enrolling post MI low left ventricular ejection fraction (LVEF ≤35%) patients prior to or at discharge from the hospital after index MI as defined in the inclusion criteria. Prior to initiating any study specific procedures, patients needs to provide his/her consent by signing and dating an informed consent form. Inclusion/Exclusion criteria will be evaluated and the patients' medical history and baseline information will be collected. Seven days ELR monitoring will be done at discharge and at chronic phase after index MI. At 6 and 9 months telephone follow-up will be done to evaluate the health status, if there will be no in-office visit planned. At 12 months there will be a scheduled in-office visit conducted to collect the health status. All the patients will be followed-up by telephone (health status) at study end (when the last patient completed the 12 month follow-up)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Actual Study Start Date : April 2014
Actual Primary Completion Date : February 20, 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
External Loop Recorder
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
Device: External Loop Recorder
Other Names:
  • NUVANT Mobile Cardiac Telemetry (MCT) system (CorventisTM)
  • SEEQ™ External Cardiac Monitor (ECM) system (Medtronic, Inc., Minneapolis, MN)

Primary Outcome Measures :
  1. The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI [ Time Frame: 7 days post discharge ]
    Post MI mortality is higher in India than in the US and Western Europe. The hypothesis of the INSPIRE-ELR study was that occurrence of arrhythmias in the acute phase of MI will identify patients at highest risk and we evaluated the percentage clinical signification arrhythmias captured through the ELR post MI in acute phase

Secondary Outcome Measures :
  1. Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year [ Time Frame: 12 Months ]
    Analysis included all patients that completed the acute monitoring period. Based on the arrhythmias detected during the acute ELR monitoring period, patients were classified as "with arrhythmia" when during the ELR monitoring period there is any episode of ELR monitored events listed. All other patients are classified "without arrhythmia". Mortality rates after the monitoring period was estimated for both groups.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01995552

Layout table for location information
Medanta - The Medicity
Gurgaon, Haryana, India, 122001
Sponsors and Collaborators
Medtronic BRC
Layout table for additonal information
Responsible Party: Medtronic BRC Identifier: NCT01995552    
Other Study ID Numbers: Version 3.0 , 22 Apr 2015
REF/2013/10/005823 ( Other Identifier: Clinical Trial Registry - India )
First Posted: November 26, 2013    Key Record Dates
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by Medtronic BRC:
Post myocardial infarction patients with low EF.
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Ventricular Dysfunction
Ventricular Dysfunction, Left
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases