We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01995552
First Posted: November 26, 2013
Last Update Posted: September 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic BRC
  Purpose
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 Intervention
Post Myocardial Infarction Patients With Ejection Fraction Less Than or Equal to 35% Device: External Loop Recorder

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Medtronic BRC:

Primary Outcome Measures:
  • Clinically significant arrhythmias reported by ELR at acute monitoring period [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Clinically significant arrhythmias reported by ELR [ Time Frame: 8-10 weeks post MI ]
    The study is designed to collect the incidence of any post-MI arrhythmias. If an arrhythmia is detected, the patient will be managed per the physician's discretion.


Enrollment: 250
Study Start Date: April 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995552


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     History of Changes
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
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Medtronic BRC:
Post myocardial infarction patients with low EF.

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases