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Arrhythmia Detection After MI

Arrhythmia Detection After Myocardial Infarction Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05073419
Acronym
AID MI
Enrollment
200
Registered
2021-10-11
Start date
2022-08-09
Completion date
2026-12-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

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.

Interventions

OTHERStandard of Care

Routine monitoring of post AMI patient with clinic visits

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

Sponsors

Samir Saba
Lead SponsorOTHER
Abbott
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Clinical information regarding ICM implantation will be withheld from outcome assessors

Intervention model description

Pilot randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Changes to patient management90 days post AMIIncidence (frequency) of cardiac arrhythmias (bradyarrhythmia, tachyarrhythmia, pause, etc…) that lead to actionable treatment change
Time to diagnosis and/or treatment of cardiac arrhythmia90 days post AMIdays post randomization

Secondary

MeasureTime frameDescription
Changes to patient management24 monthsIncidence (frequency) of cardiac arrhythmias (bradyarrhythmia, tachyarrhythmia, pause, etc…) that lead to actionable treatment change
Mortalityat 90 daysall-cause mortality

Countries

United States

Contacts

CONTACTSamir F Saba, MD
sabas@upmc.edu412 647 2695
CONTACTMelissa Enlow
enlowms@upmc.edu412-647-1582
PRINCIPAL_INVESTIGATORSamir F Saba, MD

University of Pittsburgh Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026