Post MI Left Ventricular DysfunctionINSPIRE-ELRNCT01995552
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
A study testing External Loop Recorder in people with Post MI Left Ventricular Dysfunction, run by Medtronic BRC at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post MI Left Ventricular Dysfunction
- What is being tested?
- External Loop Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Post MI Left Ventricular Dysfunction
- Being tested
- External Loop Recorder
- Keywords
- Post myocardial infarction patients with low EF.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Loop RecorderDevice
Also called NUVANT Mobile Cardiac Telemetry (MCT) system (CorventisTM), SEEQ™ External Cardiac Monitor (ECM) system (Medtronic, Inc., Minneapolis, MN)
| Study group | Role | What they receive |
|---|---|---|
| External Loop Recorder | Other | This is a non-randomized study. All the patients will be enrolled will received the ELR system. Receives: Device: External Loop Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days post discharge
Secondary outcomes (1)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startApr 2014
- Primary completion20 Feb 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post MI Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995552
- Sponsor's protocol ID
- Version 3.0 , 22 Apr 2015
- Other IDs
- REF/2013/10/005823
- Acronym
- INSPIRE-ELR
- Status last verified
- Aug 2019
- First submitted
- 21 Nov 2013
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
- ClinicalTrials.gov ID
- NCT01995552
- Acronym / sponsor ID
- INSPIRE-ELR / Version 3.0 , 22 Apr 2015
- Conditions
- Post MI Left Ventricular Dysfunction
- Keywords
- Post myocardial infarction patients with low EF.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Apr 2014 (actual)
- Primary completion
- 20 Feb 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| External Loop Recorder | Other | Device: External Loop RecorderThis is a non-randomized study. All the patients will be enrolled will received the ELR system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Loop RecorderAlso: NUVANT Mobile Cardiac Telemetry (MCT) system (CorventisTM), SEEQ™ External Cardiac Monitor (ECM) system (Medtronic, Inc., Minneapolis, MN) | Device | External Loop Recorder |
Primary outcome
The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI
Time frame: 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
1 secondary outcome
Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Loop Recorder in people with Post MI Left Ventricular Dysfunction, run by Medtronic BRC at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI (time frame: 7 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.