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

Primary Purpose

Post MI Left Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
External Loop Recorder
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post MI Left Ventricular Dysfunction focused on measuring Post myocardial infarction patients with low EF.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medanta - The Medicity

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

External Loop Recorder

Arm Description

This is a non-randomized study. All the patients will be enrolled will received the ELR system.

Outcomes

Primary Outcome Measures

The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI
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

Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year
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.

Full Information

First Posted
November 21, 2013
Last Updated
August 19, 2019
Sponsor
Medtronic BRC
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01995552
Brief Title
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Acronym
INSPIRE-ELR
Official Title
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
February 20, 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post MI Left Ventricular Dysfunction
Keywords
Post myocardial infarction patients with low EF.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Loop Recorder
Arm Type
Other
Arm Description
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
Intervention Type
Device
Intervention Name(s)
External Loop Recorder
Other Intervention Name(s)
NUVANT Mobile Cardiac Telemetry (MCT) system (CorventisTM), SEEQ™ External Cardiac Monitor (ECM) system (Medtronic, Inc., Minneapolis, MN)
Primary Outcome Measure Information:
Title
The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI
Description
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
Time Frame
7 days post discharge
Secondary Outcome Measure Information:
Title
Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medanta - The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India

12. IPD Sharing Statement

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

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