Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05073419

Arrhythmia Detection After Myocardial Infarction Trial

Led by Samir Saba · Updated on 2026-06-05

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Samir Saba

Lead Sponsor

A

Abbott

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of implantable cardiac monitors (ICM) on managing patients after an acute myocardial infarction (AMI) to potentially improve their outcomes. Patients who experience ventricular tachycardia or fibrillation after AMI have a higher risk of sudden cardiac death, but current guidelines delay implantable cardioverter defibrillator (ICD) placement for at least 40 days post-AMI, leaving some patients unprotected during this vulnerable period. Previous studies have shown mixed results regarding timing and benefits of ICD placement, highlighting the need for better monitoring to guide treatment decisions. This trial compares two groups of post-AMI patients: one receiving standard care with routine clinic visits, and the other receiving standard care plus ICM implantation through a small skin incision within 21 days of their AMI. The ICM allows continuous remote monitoring of heart rhythms to detect arrhythmias that may require intervention. The study is randomized and single-blinded, aiming to assess how ICM use changes patient management and the timing of diagnosis or treatment of cardiac arrhythmias. Participants will be followed for up to 24 months, with primary outcomes measured at 90 days, including changes in patient management and time to arrhythmia diagnosis or treatment. Secondary outcomes include mortality at 90 days and 24 months, as well as longer-term management changes. Researchers will use remote monitoring data, clinical assessments, and hospital records to evaluate the effects of ICM on care decisions and patient survival after AMI.

CONDITIONS

Brief Title

Arrhythmia Detection After MI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults, age 18 years or older
  • Diagnosis of acute myocardial infarction (STEMI or NSTEMI)
  • Willing to provide written informed consent
  • Expected to be discharged from hospital within 7 days of AMI
  • Willing to receive implantable cardiac monitor insertion within 21 days of index AMI
Not Eligible

You will not qualify if you...

  • Existing pacemaker, implantable cardioverter defibrillator, implantable cardiac monitor, or any other implantable cardiac electronic device
  • Pregnant
  • Acute myocardial infarction occurred more than 21 days before screening
  • Unwilling or unable to receive implantable cardiac monitor insertion within 21 days post AMI
  • Planned implantable cardioverter defibrillator implant, planned coronary artery bypass graft surgery, or any open-heart surgery (e.g., for severe valvular disease)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 21 days post-acute myocardial infarction

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Within 21 days post-AMI

Participants assigned to the experimental arm receive an implantable cardiac monitor (ICM) through a small incision under the skin. Participants in the control arm receive standard post-AMI care.

1 visit for ICM implantation (in-person) or standard care visits

Monitoring

Duration - Up to 24 months

Participants are monitored remotely or through clinic visits to detect cardiac arrhythmias and manage post-AMI care.

Clinic visits and remote monitoring as part of routine care over 24 months

Trial Site Locations

Total: 1 location

1

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

S

Samir F Saba, MD

M

Melissa Enlow

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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