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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)

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ClinicalTrials.gov Identifier: NCT01995552
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic BRC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Post MI Left Ventricular Dysfunction
Intervention Device: External Loop Recorder
Enrollment 250
Recruitment Details The study enrolled acute post MI patients with a reduced LVEF (≤35%) one day before or on the day of discharge from hospital after index MI. There is no control group in this study. The study was conducted in India and in multi specialty hospitals
Pre-assignment Details The first patient was enrolled on April 29, 2014. Enrollment continued until the 250th patient was enrolled on January 31, 2016. out of 250, patients, there were 233 patients in the analysis cohort, with at least 72 hours of monitoring documented in the ELR device data or a clinically significant arrhythmia in the first 72 hours of monitoring.
Arm/Group Title External Loop Recorder (Single Arm)
Hide Arm/Group Description

This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder) After enrollment in the study the following visits are scheduled:

  • Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.
  • Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.
  • 12-month follow-up visit: In office visit, health status questionnaire
  • Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up).
Period Title: Overall Study
Started [1] 250 [2]
Completed 233 [3]
Not Completed 17
Reason Not Completed
Protocol Violation             1
Lack of Efficacy             15
Death             1
[1]
The study required to enroll 250 patients:
[2]
There were 249 patients were included for Baseline cohort and 233 in analysis cohort
[3]
There were 233 patients who were eligible for primary objective analysis
Arm/Group Title External Loop Recorder (Single Arm)
Hide Arm/Group Description

This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder)

After enrollment in the study the following visits are scheduled:

  • Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.
  • Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.
  • 12-month follow-up visit: In office visit, health status questionnaire
  • Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up).
Overall Number of Baseline Participants 250
Hide Baseline Analysis Population Description
The baseline cohort consists of 250 patients and the analysis cohort of 233. There were 17 patients excluded from the analysis because they were not fulfilling the required criteria of analysis as per the protocol.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants
<=18 years
0
   0.0%
Between 18 and 65 years
192
  77.1%
>=65 years
57
  22.9%
[1]
Measure Analysis Population Description: 1 patient was excluded due to LVEF >35% which is the exclusion criteria
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 250 participants
56  (12)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants
Female
34
  13.7%
Male
215
  86.3%
[1]
Measure Analysis Population Description: one patient was excluded due to LVEF>35 which is the exclusion criteria
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 250 participants
250
Ejection Fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  % Ejection Fraction
Number Analyzed 249 participants
31.7  (5.8)
[1]
Measure Analysis Population Description: The baseline cohort consists of 249 patients and the analysis cohort of 233.
1.Primary Outcome
Title The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title External Loop Recorder (Single Arm)
Hide Arm/Group Description:
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
Overall Number of Participants Analyzed 233
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of analyzed population
48.5
(42.2 to 54.9)
2.Secondary Outcome
Title Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
There were total 28 deaths reported
Arm/Group Title Acute Phase (With Arrhythmias) Acute Phase (Without Arrhythmias)
Hide Arm/Group Description:
Patients were classified as "with significant arrhythmia" when during the ELR monitoring period and mortality was seen during 12 month follow-up.
Patients were classified as "without significant arrhythmia" when during the ELR monitoring period and mortality was seen during 12 month follow-up.
Overall Number of Participants Analyzed 113 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Mortality
19.6
(13.3 to 28.2)
3.5
(1.3 to 9.0)
Time Frame All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
Adverse Event Reporting Description As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
 
Arm/Group Title External Loop Recorder (Single Arm)
Hide Arm/Group Description For this study, only Deaths and Cardiovascular Related Serious Adverse Events were collected. There were in total 28 deaths and 49 SAEs reported. No system or procedure related SAE were reported
All-Cause Mortality
External Loop Recorder (Single Arm)
Affected / at Risk (%)
Total   28/249 (11.24%)    
Hide Serious Adverse Events
External Loop Recorder (Single Arm)
Affected / at Risk (%) # Events
Total   49/249 (19.68%)    
Cardiac disorders   
Cardiac arrest  [1]  4/249 (1.61%)  4
Acute left ventricular failure  [2]  3/249 (1.20%)  3
Cardiac failure congestive  [3]  3/249 (1.20%)  3
Coronary artery disease  [4]  3/249 (1.20%)  3
Acute myocardial infarction  [5]  2/249 (0.80%)  2
Ventricular tachyarrhythmia  [6]  3/249 (1.20%)  3
Ventricular tachycardia  [7]  3/249 (1.20%)  3
Angina pectoris  [8]  1/249 (0.40%)  1
Angina unstable  [9]  1/249 (0.40%)  1
Atrial fibrillation  [10]  1/249 (0.40%)  1
Atrioventricular block complete  [11]  1/249 (0.40%)  1
Cardiac failure  [12]  1/249 (0.40%)  1
Cardiac failure acute  [13]  1/249 (0.40%)  1
Left ventricular dysfunction  [14]  1/249 (0.40%)  1
Left ventricular failure  [15]  1/249 (0.40%)  1
General disorders   
Death  [16]  5/249 (2.01%)  5
Unevaluable event  [17]  2/249 (0.80%)  2
Chest discomfort  [18]  1/249 (0.40%)  1
Multi-organ failure  [19]  1/249 (0.40%)  1
Sudden cardiac death  [20]  1/249 (0.40%)  1
Vascular stent restenosis  [21]  1/249 (0.40%)  1
Nervous system disorders   
Cerebral infarction  [22]  1/249 (0.40%)  1
Cerebrovascular disorder  [23]  1/249 (0.40%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  [24]  2/249 (0.80%)  2
Acute pulmonary oedema  [25]  1/249 (0.40%)  1
Chronic obstructive pulmonary disease   1/249 (0.40%)  1
Dyspnoea exertional  [26]  1/249 (0.40%)  1
Hypoxia  [27]  1/249 (0.40%)  1
Aortic stenosis  [28]  1/249 (0.40%)  1
Indicates events were collected by systematic assessment
[1]
Cardiac arrest
[2]
Acute left ventricular failure
[3]
Cardiac failure congestive
[4]
Coronary artery disease
[5]
Acute myocardial infarction
[6]
Ventricular tachyarrhythmia
[7]
Ventricular tachycardia
[8]
Angina pectoris
[9]
Angina unstable
[10]
Atrial fibrillation
[11]
Atrioventricular block complete
[12]
Cardiac failure
[13]
Cardiac failure acute
[14]
Left ventricular dysfunction
[15]
Left ventricular failure
[16]
Death
[17]
Unevaluable event
[18]
Chest discomfort
[19]
Multi-organ failure
[20]
Sudden cardiac death
[21]
Vascular stent restenosis
[22]
Cerebral infarction
[23]
Cerebrovascular disorder
[24]
Dyspnoea
[25]
Acute pulmonary oedema
[26]
Dyspnoea exertional
[27]
Hypoxia
[28]
Aortic stenosis
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
External Loop Recorder (Single Arm)
Affected / at Risk (%) # Events
Total   0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vinay Rajan Ph.D
Organization: India Medtronic Pvt. Ltd.
Phone: +91 22.3307.4700
EMail: vinay.rajan@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT01995552    
Other Study ID Numbers: Version 3.0 , 22 Apr 2015
REF/2013/10/005823 ( Other Identifier: Clinical Trial Registry - India )
First Submitted: November 21, 2013
First Posted: November 26, 2013
Results First Submitted: August 17, 2018
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019