Myocardial InfarctionPhase 2NCT02492243
Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)
A Phase 2 study testing PCI and ILR implantation in people with Myocardial Infarction, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The trial will inform whether detection of ventricular arrhythmias by means of implantable loop recorder (ILR) can help to predict SCD in the large population of survivors of a myocardial infarction with preserved left ventricular function, EF>40%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- PCI and ILR implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed
- Documented myocardial infarction in the 7days prior to enrolment
- Age > 18 yrs
- Left ventricular ejection fraction >=40% as assessed by echocardiography within 7 days window after MI.
Who cannot join
- subject is unwilling or unable to comply with the study procedures
- documented ventricular tachycardia or survived cardiac arrest outside of an acute coronary syndrome
- Subject has indications for active implanted cardiac medical device (IPG, ICD, CRT).
- contraindications for implantation of a ICM - Planned CABG procedure
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, 630055
About this study
Official title: Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction and pREServed Left venTricle Ejection Fraction
The trial will inform whether detection of ventricular arrhythmias by means of implantable loop recorder (ILR) can help to predict SCD in the large population of survivors of a myocardial infarction with preserved left ventricular function, EF>40%. This may improve risk stratification in these patients, and can inform on the clinical use of subcutaneous monitors to identify post-infarction populations in need for an intervention to prevent sudden death.
- Conditions
- Myocardial Infarction
- Being tested
- PCI, ILR implantation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIDevice
ILR implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients with documented myocardial infarction in the 7days prior to enrolment and left ventricular ejection fraction >=40% as assessed by echocardiography within 7 days window after MI,who are not candidate to ICD/CRT/IPG implantation after PCI undergo ILR implantation Receives: Device: PCI; Device: ILR implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac arrest
Measured: 24 months
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
Measured: 24 months
Ventricular fibrillation
Measured: 24 months
Atrial Fibrillation (symptomatic and asymptomatic)
Measured: 24 months
Documented Arrhythmic death without evidence of primary non cardiac cause
Measured: 24 months
Secondary outcomes (5)
All Arrhythmic events recorded by ILR
Measured: 24 months
Changing in treatment strategy, based on physician decision
Measured: 24 months
Invasive procedures for arrhythmia treatment
Measured: 24 months
Changing in medical treatment (anticoagulation, antiarrhythmic drugs)
Measured: 24 months
CV events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492243
- Sponsor's protocol ID
- A V1CAMI 2010
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Romanov A, Martinek M, Purerfellner H, Chen S, De Melis M, Grazhdankin I, Ponomarev D, Losik D, Strelnikov A, Shabanov V, Karaskov A, Pokushalov E. Incidence of atrial fibrillation detected by continuous rhythm monitoring after acute myocardial infarction in patients with preserved left ventricular ejection fraction: results of the ARREST study. Europace. 2018 Feb 1;20(2):263-270. doi: 10.1093/europace/euw344.
PubMed 28069838
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction and pREServed Left venTricle Ejection Fraction
- ClinicalTrials.gov ID
- NCT02492243
- Acronym / sponsor ID
- A V1CAMI 2010
- Conditions
- Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- Aug 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will inform whether detection of ventricular arrhythmias by means of implantable loop recorder (ILR) can help to predict SCD in the large population of survivors of a myocardial infarction with preserved left ventricular function, EF>40%. This may improve risk stratification in these patients, and can inform on the clinical use of subcutaneous monitors to identify post-infarction populations in need for an intervention to prevent sudden death.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: PCI, Device: ILR implantationPatients with documented myocardial infarction in the 7days prior to enrolment and left ventricular ejection fraction >=40% as assessed by echocardiography within 7 days window after MI,who are not candidate to ICD/CRT/IPG implantation after PCI undergo ILR implantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent signed
- Documented myocardial infarction in the 7days prior to enrolment
- Age > 18 yrs
- Left ventricular ejection fraction >=40% as assessed by echocardiography within 7 days window after MI.
Key exclusion criteria (4 listed)
- subject is unwilling or unable to comply with the study procedures
- documented ventricular tachycardia or survived cardiac arrest outside of an acute coronary syndrome
- Subject has indications for active implanted cardiac medical device (IPG, ICD, CRT).
- contraindications for implantation of a ICM - Planned CABG procedure
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 |
|---|---|---|
| PCI | Device | Group 1 |
| ILR implantation | Device | Group 1 |
Primary outcome
Cardiac arrest
Time frame: 24 months
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
Time frame: 24 months
Ventricular fibrillation
Time frame: 24 months
Atrial Fibrillation (symptomatic and asymptomatic)
Time frame: 24 months
Documented Arrhythmic death without evidence of primary non cardiac cause
Time frame: 24 months
5 secondary outcomes
All Arrhythmic events recorded by ILR
Time frame: 24 months
Changing in treatment strategy, based on physician decision
Time frame: 24 months
Invasive procedures for arrhythmia treatment
Time frame: 24 months
Changing in medical treatment (anticoagulation, antiarrhythmic drugs)
Time frame: 24 months
CV events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Derived from this study: PubMed 28069838Romanov A, Martinek M, Purerfellner H, Chen S, De Melis M, Grazhdankin I, Ponomarev D, Losik D, Strelnikov A, Shabanov V, Karaskov A, Pokushalov E. Incidence of atrial fibrillation detected by continuous rhythm monitoring after acute myocardial infarction in patients with preserved left ventricular ejection fraction: results of the ARREST study. Europace. 2018 Feb 1;20(2):263-270. doi: 10.1093/europace/euw344.
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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 Phase 2 study testing PCI and ILR implantation in people with Myocardial Infarction, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 4 inclusion and 4 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 8 Jul 2015. 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 Russia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac arrest (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492243, which also lists 1 linked publication.
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 8 Jul 2015.