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Acute Myocardial InfarctionAID MINCT05073419

Arrhythmia Detection After MI

A study testing ICM Implantation in people with Acute Myocardial Infarction, run by Samir Saba at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Patients post acute myocardial infarction (AMI) have a high risk of mortality but the use of an implantable defibrillator in the early aftermath of an AMI has not been shown to improve patients' survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
ICM Implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
9 Aug 2022to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Adults, age 18 years or older
  • AMI (STEMI and NSTEMI)
  • Willing to give written informed consent
  • Expected discharge from hospital within 7 days of AMI
  • Willing to receive ICM insertion within 21 days of index AMI

Who cannot join

  • Existing pacemaker, ICD, ICM, or any other implantable cardiac electronic device
  • Pregnant
  • Index AMI was more than 21 days
  • Unwilling/cannot insert ICM within 21 days post AMI
  • Planned ICD implant, planned CABG or any open-heart surgery (e.g. for severe valvular disease)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Samir F Saba, MD contact

412 647 2695

sabas@upmc.edu

Melissa Enlow contact

412-647-1582

enlowms@upmc.edu

United States1 site, 1 recruiting
  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

    Eric Pasquantonio, 14126478210, pasquantonioej@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: Arrhythmia Detection After Myocardial Infarction Trial

Patients post acute myocardial infarction (AMI) have a high risk of mortality but the use of an implantable defibrillator in the early aftermath of an AMI has not been shown to improve patients' survival. The VEST trial recently demonstrated an improved overall survival in post AMI patients with the use of a wearable defibrillator. The same improvement was not demonstrated for the risk of sudden cardiac death. Monitoring patients after AMI using an implantable cardiac monitor (ICM) may document findings that can impact patient management and eventually improve their outcomes. We are therefore conducting the AID MI trial to examine the impact of ICM on patient management in the post AMI setting.

Read the detailed description

Patients who have ventricular tachycardia or fibrillation at least 48 hours after an acute myocardial infarction (AMI) have a higher risk of sudden cardiac death. Current guidelines recommend that for primary prevention of sudden cardiac death, patients with left ventricular ejection fraction (LVEF) ≤ 35% should wait at least 40 days post-AMI or 90 days post revascularization prior to receiving an implantable cardioverter defibrillator (ICD). This period of time potentially leaves a vulnerable population without protection from sudden cardiac death (SCD).

The landmark MADIT I and MADIT II trials demonstrated that ICD therapy was associated with significantly improved survival in patients with ischemic cardiomyopathy at any interval of time. The DINAMIT study demonstrated that ICD placement less than 40 days after AMI had a reduction in arrhythmic mortality at the cost of an increase in non-arrhythmic mortality. Results from these and other studies suggest that the risk of SCD after AMI may be time-dependent and that patients at increased risk for SCD are also at increased risk for death from other causes. Thus, there is a need for additional studies to identify subsets of patients with arrhythmias that may benefit from other therapeutic interventions such as ablations, anti-arrhythmic medications, implantable cardiac devices, or other therapies.

The CARISMA study was the first study to document the incidence of cardiac arrhythmias in post-AMI patients with left ventricular dysfunction (LVEF≤40%) using an implantable loop recorder. Results showed high incidences of arrhythmias such as new-onset AF (27.6%) and high-degree AV block (9.8%). Subsequent studies showed that these arrhythmias were associated with increased risk of major cardiovascular events such as heart failure, ventricular tachyarrhythmias, stroke, reinfarction, or cardiac death.

It has been shown that utilizing remote monitoring as part of clinical care in patients with cardiac implantable electronic devices is associated with improved all-cause survival; the magnitude of survival increases with the degree of adherence to remote monitoring and the timeliness to enroll and activate in remote monitoring shortly after device implantation.

These studies suggest the need for further investigation and evaluation of acute and long-term cardiac monitoring in post-AMI patients, in an effort to identify patients at greatest risk, inform clinical decision making and potentially reduce the risk of all-cause mortality. In addition, the ability to remotely monitor patients may minimize the time to diagnosis and enable early intervention in this patient population.

Being tested
Standard of Care, ICM Implantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of CareOther

    Also called Control

    Routine monitoring of post AMI patient with clinic visits

  • ICM ImplantationDevice

    Also called ICM

    Implantation of ICM through small incision (2 mm) under the skin

Study groups in NCT05073419
Study groupRoleWhat they receive
ControlActive comparatorPost-AMI patients in this arm will receive standard of care
Receives: Other: Standard of Care
ICMExperimentalPost-AMI patients in this arm will receive standard of care and an ICM
Receives: Device: ICM Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes to patient management

    Incidence (frequency) of cardiac arrhythmias (bradyarrhythmia, tachyarrhythmia, pause, etc…) that lead to actionable treatment change

    Measured: 90 days post AMI

  2. Time to diagnosis and/or treatment of cardiac arrhythmia

    days post randomization

    Measured: 90 days post AMI

Secondary outcomes (3)
  1. Changes to patient management

    Incidence (frequency) of cardiac arrhythmias (bradyarrhythmia, tachyarrhythmia, pause, etc…) that lead to actionable treatment change

    Measured: 24 months

  2. Mortality

    all-cause mortality

    Measured: at 90 days

  3. Mortality

    All-cause mortality

    Measured: at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start9 Aug 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05073419
Sponsor's protocol ID
STUDY21060027
Acronym
AID MI
Status last verified
Jun 2026
First submitted
28 Sep 2021
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Publication of protocol, methods, results in aggregates

Questions about this trial

What is this clinical trial studying?

A study testing ICM Implantation in people with Acute Myocardial Infarction, run by Samir Saba at 1 site in United States.

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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Samir F Saba, MD (412 647 2695, sabas@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes to patient management (time frame: 90 days post AMI). The study lists 2 primary outcomes in all. 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 5 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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