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

NCT01995552 | Completed Results

• 2 other identifiers: Version 3.0 , 22 Apr 2015REF/2013/10/005823
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Post MI Left Ventricular Dysfunction

Keywords

Post myocardial infarction patients with low EF.

Outcome Measures

Primary Outcomes (1)

• 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

  7 days post discharge

Secondary Outcomes (1)

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

  12 Months

Study Arms (1)

External Loop Recorder

OTHER

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

Device: External Loop Recorder

Interventions

External Loop Recorder DEVICE

Also known as: NUVANT Mobile Cardiac Telemetry (MCT) system (CorventisTM), SEEQ™ External Cardiac Monitor (ECM) system (Medtronic, Inc., Minneapolis, MN)

External Loop Recorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic BRC: lead
• Medtronic: collaborator

Study Sites (1)

Medanta - The Medicity

Gurgaon, Haryana, 122001, India

Location

MeSH Terms

Interventions

Mucociliary Clearance; Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Vinay Rajan Ph.D
• Organization: India Medtronic Pvt. Ltd.

vinay.rajan@medtronic.com

+91 22.3307.4700

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: April 1, 2014
• Primary Completion: February 20, 2016
• Study Completion: April 1, 2017
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-08

Locations

IN (1)