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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medtronic Bakken Research Center
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01995552
First received: November 21, 2013
Last updated: August 12, 2014
Last verified: August 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 Bakken Research Center:

Primary Outcome Measures:
  • Clinically significant arrhythmias reported by ELR at acute monitoring period [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinically significant arrhythmias reported by ELR [ Time Frame: 8-10 weeks post MI ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (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 Name: NUVANT MCT system (Corventis, Inc., San Jose, CA)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must provide written informed consent/data release consent to participate in the study.
  2. Acute Myocardial Infarction (STEMI or non-STEMI) within the last 10 days based on ESC/ACC/AHA/WHF criteria (Thygesen, 2012) matching the following criteria:

    Rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:

    1. Symptoms of ischaemia.
    2. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
    3. Development of pathological Q waves in the ECG.
    4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
    5. Identification of an intracoronary thrombus by angiography.
  3. LVEF ≤35% as measured by echocardiography (Simpson's method, biplane) one day before or on the day of hospital discharge

Exclusion Criteria:

  1. Patients who cannot be discharged from the hospital within14 days after index Myocardial Infarction event
  2. Age < 18 years
  3. Psychologically incapacitated
  4. Patient is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
  5. Patients contraindicated for NUVANT system
  6. Comorbidities likely to limit survival to less than the minimal study duration (12 months)
  7. 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)
  8. Patients with an existing pacemaker or ICD implanted.
  9. Patients that are dialysis dependent at discharge
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995552

Contacts
Contact: Dr. Balbir Singh, DM (Cardiology) 0124 441 1441 balbir.singh@medanta.org

Locations
India
Medanta - The Medicity Recruiting
Gurgaon, Haryana, India, 122001
Contact: Balbir Singh, DM (Cardiology)    0124 441 1441    balbir.singh@medanta.org   
Principal Investigator: Dr. Balbir Singh, DM (Cardiology)         
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01995552     History of Changes
Other Study ID Numbers: Version 1.0 , 07 October 2013, REF/2013/10/005823
Study First Received: November 21, 2013
Last Updated: August 12, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Medtronic Bakken Research Center:
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

ClinicalTrials.gov processed this record on October 16, 2014