Post MI Left Ventricular Dysfunction
Conditions
Keywords
Post myocardial infarction patients with low EF.
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)
Interventions
DEVICEExternal Loop Recorder
Sponsors
Medtronic
Medtronic BRC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI | 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
| Measure | Time frame | Description |
|---|---|---|
| Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year | 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. |
Countries
India
Participant flow
Recruitment details
The study enrolled acute post MI patients with a reduced LVEF (≤35%) one day before or on the day of discharge from hospital after index MI. There is no control group in this study. The study was conducted in India and in multi specialty hospitals
Pre-assignment details
The first patient was enrolled on April 29, 2014. Enrollment continued until the 250th patient was enrolled on January 31, 2016. out of 250, patients, there were 233 patients in the analysis cohort, with at least 72 hours of monitoring documented in the ELR device data or a clinically significant arrhythmia in the first 72 hours of monitoring.
Participants by arm
| Arm | Count |
|---|---|
| External Loop Recorder (Single Arm) This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder)
After enrollment in the study the following visits are scheduled:
* Baseline (day of discharge or one day before discharge after index MI). the main activities were Patient demographics, apply ELR, 12 lead ECG, LVEF etc.
* Chronic phase follow-up visit: apply ELR, 12 lead ECG, LVEF etc. 6 and 9 months follow-up: Telephonic health status if patient is not seen.
* 12-month follow-up visit: In office visit, health status questionnaire
* Extended follow-up beyond 12 months: Telephonic health status at the study end (when the last patient completes the 12 months follow up). | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 15 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | External Loop Recorder (Single Arm) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 57 Participants | — |
| Age, Categorical Between 18 and 65 years | 192 Participants | — |
| Age, Continuous | 56 Years STANDARD_DEVIATION 12 | — |
| Ejection Fraction | 31.7 % Ejection Fraction STANDARD_DEVIATION 5.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment India | 250 participants | — |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 215 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 28 / 249 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 49 / 249 |
Outcome results
Primary
The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI
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
Time frame: 7 days post discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| External Loop Recorder (Single Arm) | 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 |
Secondary
Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year
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.
Time frame: 12 Months
Population: There were total 28 deaths reported
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| External Loop Recorder (Single Arm) | 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 percentage of Mortality |
| Acute Phase (Without Arrhythmias) | Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year | 3.5 percentage of Mortality |