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

• 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: Medtronic BRC
• 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

Participant Flow

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)
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

Baseline Characteristics

Arm/Group Title		External Loop Recorder (Single Arm)
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
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.

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	External Loop Recorder (Single Arm)
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
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

Outcome Measure Data

Analysis Population Description

There were total 28 deaths reported

Arm/Group Title	Acute Phase (With Arrhythmias)	Acute Phase (Without Arrhythmias)
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)

Adverse Events

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)
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Vinay Rajan Ph.D
• Organization: India Medtronic Pvt. Ltd.
• Phone: +91 22.3307.4700
• EMail: vinay.rajan@medtronic.com

• 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