Arrhythmia Detection After MI

NCT ID: NCT05073419

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2026-10-01

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.

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Routine monitoring of post AMI patient with clinic visits

ICM

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

Group Type: EXPERIMENTAL

ICM Implantation

Intervention Type: DEVICE

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

Interventions

Standard of Care

Routine monitoring of post AMI patient with clinic visits

Intervention Type: OTHER

ICM Implantation

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

Intervention Type: DEVICE

Other Intervention Names

Control; ICM

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Samir Saba

OTHER

Sponsor Role: lead

Responsible Party

Samir Saba

Division Chief of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samir F Saba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samir F Saba, MD

Role: CONTACT

sabas@upmc.edu

412 647 2695

Melissa Enlow

Role: CONTACT

enlowms@upmc.edu

412-647-1582

Facility Contacts

Eric Pasquantonio

Role: primary

pasquantonioej@upmc.edu

14126478210

Other Identifiers

STUDY21060027

Identifier Type: -

Identifier Source: org_study_id