Recruiting

Observational Study

Sponsor:

Samir Saba

Code:

NCT05073419

Conditions

Acute Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

ICM Implantation

Study Details

Brief 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.

Conditions

Acute Myocardial Infarction

Study ID

NCT05073419

Start date

Aug 9, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

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

experimental: ICM

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

Interventions

Standard of Care

Routine monitoring of post AMI patient with clinic visits

ICM Implantation

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

Primary outcome measure

  • Changes to patient management [ Time Frame: 90 days post AMI ]
  • Time to diagnosis and/or treatment of cardiac arrhythmia [ Time Frame: 90 days post AMI ]

Central Contacts and Locations

Central contacts

Samir F Saba, MD

412 647 2695sabas@upmc.edu

Melissa Enlow

412-647-1582enlowms@upmc.edu

Locations

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Eric Pasquantonio

14126478210pasquantonioej@upmc.edu

More Information

Sponsor

Samir Saba

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samir Saba on 2026-06-05.