Acute Myocardial InfarctionAID MINCT05073419
Arrhythmia Detection After MI
A study testing ICM Implantation in people with Acute Myocardial Infarction, run by Samir Saba at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- ICM Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Eric Pasquantonio, 14126478210, pasquantonioej@upmc.edu
About this study
Official title: Arrhythmia Detection After Myocardial Infarction Trial
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.
Read the 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
- Being tested
- Standard of Care, ICM Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Also called Control
Routine monitoring of post AMI patient with clinic visits
ICM ImplantationDevice
Also called ICM
Implantation of ICM through small incision (2 mm) under the skin
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Post-AMI patients in this arm will receive standard of care Receives: Other: Standard of Care |
| ICM | Experimental | Post-AMI patients in this arm will receive standard of care and an ICM Receives: Device: ICM Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to patient management
Incidence (frequency) of cardiac arrhythmias (bradyarrhythmia, tachyarrhythmia, pause, etc…) that lead to actionable treatment change
Measured: 90 days post AMI
Time to diagnosis and/or treatment of cardiac arrhythmia
days post randomization
Measured: 90 days post AMI
Secondary outcomes (3)
Changes to patient management
Incidence (frequency) of cardiac arrhythmias (bradyarrhythmia, tachyarrhythmia, pause, etc…) that lead to actionable treatment change
Measured: 24 months
Mortality
all-cause mortality
Measured: at 90 days
Mortality
All-cause mortality
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start9 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samir Saba
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Samir Saba, University of Pittsburgh
- Investigators
- Samir F Saba, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073419
- Sponsor's protocol ID
- STUDY21060027
- Acronym
- AID MI
- Status last verified
- Jun 2026
- First submitted
- 28 Sep 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Publication of protocol, methods, results in aggregates
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmia Detection After Myocardial Infarction Trial
- ClinicalTrials.gov ID
- NCT05073419
- Acronym / sponsor ID
- AID MI / STUDY21060027
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samir SabaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard of CarePost-AMI patients in this arm will receive standard of care |
| ICM | Experimental | Device: ICM ImplantationPost-AMI patients in this arm will receive standard of care and an ICM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareAlso: ControlRoutine monitoring of post AMI patient with clinic visits | Other | Control |
| ICM ImplantationAlso: ICMImplantation of ICM through small incision (2 mm) under the skin | Device | ICM |
Primary outcome
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
Time to diagnosis and/or treatment of cardiac arrhythmia
Time frame: 90 days post AMI
days post randomization
3 secondary outcomes
Changes to patient management
Time frame: 24 months
Mortality
Time frame: at 90 days
Mortality
Time frame: at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. Publication of protocol, methods, results in aggregates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samir F Saba, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICM Implantation in people with Acute Myocardial Infarction, run by Samir Saba at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samir F Saba, MD (412 647 2695, sabas@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to patient management (time frame: 90 days post AMI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.