Clinical trial NCT01995552: IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Official title: IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post MI Left Ventricular Dysfunction
Keywords: Post myocardial infarction patients with low EF.
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2013-11-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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)

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

Primary outcomes:
measure: The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI
timeFrame: 7 days post discharge
Secondary outcomes:
measure: Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year
timeFrame: 12 Months
Other outcomes:
Locations:
city: Gurgaon
country: India
facility: Medanta - The Medicity
state: Haryana
Study officials:
References: