N/A
N=250
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Post MI Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01995552 ↗Enrolled (actual)
250
Serious AEs
19.7%
Results posted
Aug 2019
Primary outcome: Primary: The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI — 48.5 percentage of analyzed population
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- External Loop Recorder (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic BRC
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI |
48.5 | — |
| SECONDARY Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year |
19.6; 3.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01995552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.