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

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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:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic BRC

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE August 17, 2018
Results First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date February 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Clinically significant arrhythmias reported by ELR at acute monitoring period [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Official Title  ICMJE IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Post MI Left Ventricular Dysfunction
Intervention  ICMJE Device: External Loop Recorder
Other Names:
  • NUVANT Mobile Cardiac Telemetry (MCT) system (CorventisTM)
  • SEEQ™ External Cardiac Monitor (ECM) system (Medtronic, Inc., Minneapolis, MN)
Study Arms  ICMJE External Loop Recorder
This is a non-randomized study. All the patients will be enrolled will received the ELR system.
Intervention: Device: External Loop Recorder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2016)
250
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
300
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date February 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995552
Other Study ID Numbers  ICMJE Version 3.0 , 22 Apr 2015
REF/2013/10/005823 ( Other Identifier: Clinical Trial Registry - India )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic BRC
Study Sponsor  ICMJE Medtronic BRC
Collaborators  ICMJE Medtronic
Investigators  ICMJE Not Provided
PRS Account Medtronic BRC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP