Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - Up to 21 days post-acute myocardial infarction
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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