Post MI Left Ventricular Dysfunction Clinical Trial
— INSPIRE-ELROfficial title:
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
| Verified date | August 2019 |
| Source | Medtronic BRC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | April 2017 |
| Est. primary completion date | February 20, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Medanta - The Medicity | Gurgaon | Haryana |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic BRC | Medtronic |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | 7 days post discharge | |
| 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. | 12 Months |