Ignite Creation Date:
2024-05-06 @ 2:12 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01995552
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2013-11-21
Brief Title:
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders INSPIRE-ELR Study
Sponsor:
Medtronic BRC
Organization:
Medtronic BRC
Study Overview
Official Title:
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders INSPIRE-ELR Study
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE-ELR
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 hisher consent by signing and dating an informed consent form InclusionExclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| REF201310005823 | OTHER | Clinical Trial Registry - India | None |