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NCT Number: NCT05073419

Arrhythmia Detection After MI

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Eric Pasquantonio

CONTACT

[email protected]

14126478210

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard of care

Other

Routine monitoring of post AMI patient with clinic visits

Other names: Control

ICM Implantation

Device

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

Other names: ICM

Primary outcomes

  1. Changes to patient management

    Time frame: 90 days post AMI

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

  2. Time to diagnosis and/or treatment of cardiac arrhythmia

    Time frame: 90 days post AMI

    days post randomization

Secondary outcomes

  1. Changes to patient management

    Time frame: 24 months

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

  2. Mortality

    Time frame: at 90 days

    all-cause mortality

  3. Mortality

    Time frame: at 24 months

    All-cause mortality

Other outcomes

  1. Depression and Anxiety Scale

    Time frame: at 90 days

    Hospital Anxiety and Depression Scale (HADS) Minimum 0 and maximum 21 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

  2. Depression and Anxiety Scale

    Time frame: at 24 months

    Hospital Anxiety and Depression Scale (HADS) Minimum 0 and maximum 21 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

  3. Physical and Mental Health

    Time frame: at 90 days

    PROMIS-29 scale Scale ranges from 29 to 145 with a higher number indicating better physical and mental health

  4. Physical and Mental Health

    Time frame: at 24 months

    PROMIS-29 scale Scale ranges from 29 to 145 with a higher number indicating better physical and mental health

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Enlow

CONTACT

[email protected]

412-647-1582

Samir F Saba, MD

CONTACT

[email protected]

412 647 2695

Sponsors and collaborators

Lead sponsor

Samir Saba

Other

Collaborators

  • Abbott

Registry information

Official study title

Arrhythmia Detection After Myocardial Infarction Trial

Acronym: AID MI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2021
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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