NCT05073419

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2022Oct 2026

First Submitted

Initial submission to the registry

September 28, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

August 9, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

4.1 years

First QC Date

September 28, 2021

Last Update Submit

July 10, 2025

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • Changes to patient management

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

    90 days post AMI

  • Time to diagnosis and/or treatment of cardiac arrhythmia

    days post randomization

    90 days post AMI

Secondary Outcomes (3)

  • Changes to patient management

    24 months

  • Mortality

    at 90 days

  • Mortality

    at 24 months

Other Outcomes (4)

  • Depression and Anxiety Scale

    at 90 days

  • Depression and Anxiety Scale

    at 24 months

  • Physical and Mental Health

    at 90 days

  • +1 more other outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Standard of Care

ICM

EXPERIMENTAL

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

Device: ICM Implantation

Interventions

Standard of CareOTHER

Routine monitoring of post AMI patient with clinic visits

Also known as: Control
Control
ICM ImplantationDEVICE

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

Also known as: ICM
ICM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Samir F Saba, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samir F Saba, MD

CONTACT

412 647 2695sabas@upmc.edu

Melissa Enlow

CONTACT

412-647-1582enlowms@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinical information regarding ICM implantation will be withheld from outcome assessors
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division Chief of Cardiology

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 11, 2021

Study Start

August 9, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Publication of protocol, methods, results in aggregates

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1 year after publication of the mainmanuscript
Access Criteria
Submit request to PI Only de-identified data will be shared

Locations

US(1)