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 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.

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)

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

India

Medanta - The Medicity

Gurgaon, Haryana, India, 122001

Sponsors and Collaborators

Medtronic BRC

Medtronic

More 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 Posted: November 26, 2013
• 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:

Myocardial Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases