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RecruitingNCT05073419AID MIUpdated Jun 5, 2026

Arrhythmia Detection After MI

An interventional study of Standard of Care and ICM Implantation in Acute Myocardial Infarction, sponsored by Samir Saba. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Samir Saba · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Myocardial Infarction
03

In context

Lead sponsor

Samir Saba is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Control

    Post-AMI patients in this arm will receive standard of care

    Other: Standard of Care

  • Experimental
    ICM

    Post-AMI patients in this arm will receive standard of care and an ICM

    Device: ICM Implantation

Interventions

  • OtherStandard of Care

    Routine monitoring of post AMI patient with clinic visits

    Also known as: Control

  • DeviceICM Implantation

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

    Also known as: ICM

06

What researchers measure

Primary outcomes

  1. Changes to patient management

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

    Time frame: 90 days post AMI

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

    days post randomization

    Time frame: 90 days post AMI

Secondary outcomes

  1. Changes to patient management

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

    Time frame: 24 months

  2. Mortality

    all-cause mortality

    Time frame: at 90 days

  3. Mortality

    All-cause mortality

    Time frame: at 24 months

Other outcomes

  1. Depression and Anxiety Scale

    Hospital Anxiety and Depression Scale (HADS) Minimum 0 and maximum 21 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

    Time frame: at 90 days

  2. Depression and Anxiety Scale

    Hospital Anxiety and Depression Scale (HADS) Minimum 0 and maximum 21 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

    Time frame: at 24 months

  3. Physical and Mental Health

    PROMIS-29 scale Scale ranges from 29 to 145 with a higher number indicating better physical and mental health

    Time frame: at 90 days

  4. Physical and Mental Health

    PROMIS-29 scale Scale ranges from 29 to 145 with a higher number indicating better physical and mental health

    Time frame: at 24 months

07

Study locations

1 of 1 sites recruiting
  • UPMC Presbyterian Hospital
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Publication of protocol, methods, results in aggregates

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05073419
Lead sponsor
Samir Saba
Collaborators
Abbott
Responsible party
Samir Saba (Division Chief of Cardiology, University of Pittsburgh) — Sponsor-investigator
First posted
Oct 11, 2021
Start date
Aug 9, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 5, 2026

Study contacts

Samir F Saba, MD
Contact
sabas@upmc.edu
412 647 2695
Melissa Enlow
Contact
enlowms@upmc.edu
412-647-1582
Samir F Saba, MD
principal investigator · University of Pittsburgh Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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