200 Participants Needed

ICM Implantation for Heart Attack

(AID MI Trial)

SF
ME
Overseen ByMelissa Enlow
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Samir Saba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment ICM Implantation for Heart Attack?

Research shows that implantable cardiac monitors (ICMs) are effective in managing heart rhythm problems and improving patient outcomes in heart failure and arrhythmia cases. They help in early detection and management of heart rhythm issues, which can improve quality of life and reduce healthcare costs.12345

Is ICM implantation generally safe for humans?

ICM implantation is generally considered safe, with complications reported at a low rate. Studies have shown that the procedure is minimally invasive, and both nurse-led and physician-led implantations have been evaluated for safety.678910

How does ICM Implantation for Heart Attack differ from other treatments?

ICM (Implantable Cardioverter-Defibrillator) implantation is unique because it provides a preventive therapy for patients at risk of sudden cardiac death after a heart attack by automatically detecting and correcting life-threatening heart rhythms, unlike standard drug therapies that may not address these specific arrhythmias.1112131415

Research Team

SF

Samir Saba, MD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

This trial is for adults over 18 who've recently had a heart attack and are expected to leave the hospital within 7 days of the event. They must be willing to get an implantable cardiac monitor (ICM) within 21 days after their heart attack, and agree to give written consent. People with existing heart devices, those pregnant, or needing open-heart surgery can't participate.

Inclusion Criteria

I am 18 years old or older.
I have had a heart attack.
Willing to give written informed consent
See 2 more

Exclusion Criteria

Pregnant
I am scheduled for a heart device implant or open-heart surgery.
Your most recent heart attack was more than 21 days ago.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an implantable cardiac monitor (ICM) and standard of care

90 days
Initial visit for ICM implantation, followed by remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Regular remote monitoring and periodic in-person visits

Long-term Monitoring

Continued remote monitoring to assess long-term outcomes and patient management

24 months

Treatment Details

Interventions

  • ICM Implantation
Trial OverviewThe study is testing if monitoring patients with an ICM after a heart attack affects patient management and improves outcomes compared to standard care alone. The ICM is implanted shortly after the patient's discharge from the hospital.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ICMExperimental Treatment1 Intervention
Post-AMI patients in this arm will receive standard of care and an ICM
Group II: ControlActive Control1 Intervention
Post-AMI patients in this arm will receive standard of care

Find a Clinic Near You

Who Is Running the Clinical Trial?

Samir Saba

Lead Sponsor

Trials
4
Recruited
500+

Abbott

Industry Sponsor

Trials
760
Recruited
489,000+
Dr. Etahn Korngold profile image

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford profile image

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

In a study involving 150 participants, longer vector lengths (75 mm) significantly improved the amplitude and visibility of P-waves in electrograms, which is crucial for accurate heart monitoring.
The oblique orientation of the implant also enhanced electrogram sensing, suggesting that both vector length and angle are important factors to consider during insertable cardiac monitor (ICM) implantation for better performance.
Factors affecting electrogram sensing in an insertable cardiac monitor: Insights from surface electrocardiogram mapping analysis.Pitman, BM., Zanker, A., Lim, M., et al.[2023]
In a study of 200 pediatric and young adult patients who received insertable cardiac monitors (ICMs), a high diagnostic yield of 63% was achieved, particularly among symptomatic patients and those without structural heart disease.
The study found that 13% of patients with a positive diagnosis required further interventions such as pacemaker or implantable cardioverter-defibrillator implantation, indicating the effectiveness of ICMs in managing arrhythmias and symptoms.
A decade of insertable cardiac monitors with remote monitoring in pediatric patients.Silvetti, MS., Tamburri, I., Porco, L., et al.[2022]
In a study of 55 patients, the innovative axillary implantation approach for a long-dipole implantable cardiac monitor (ICM) showed comparable sensing performance to the traditional prepectoral method, with no significant differences in R-wave amplitude or visibility of P waves.
All patients tolerated the axillary insertion well, reporting no device-related issues, suggesting that this method is not only effective but also well-accepted by patients.
Sensing performance, safety, and patient acceptability of long-dipole cardiac monitor: An innovative axillary insertion.Bisignani, G., De Bonis, S., Bisignani, A., et al.[2018]

References

Factors affecting electrogram sensing in an insertable cardiac monitor: Insights from surface electrocardiogram mapping analysis. [2023]
A decade of insertable cardiac monitors with remote monitoring in pediatric patients. [2022]
Sensing performance, safety, and patient acceptability of long-dipole cardiac monitor: An innovative axillary insertion. [2018]
Continuous monitoring after atrial fibrillation ablation: the LINQ AF study. [2019]
The implantable cardiac monitor in heart failure patient: a possible new indication? [2023]
Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study. [2018]
Clinical evaluation of a small implantable cardiac monitor with a long sensing vector. [2021]
Patient satisfaction, safety and efficacy of nurse-led compared to physician-led implantation of cardiac monitors. [2023]
A single center experience on the clinical utility evaluation of an insertable cardiac monitor. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Adverse events of subcutaneous loop recorders: Insights from the MAUDE database. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Device interaction between cardiac contractility modulation (CCM) and subcutaneous defibrillator (S-ICD). [2021]
[The stratification and prevention of the arrhythmia risk in nonischemic dilated cardiomyopathy]. [2007]
13.United Statespubmed.ncbi.nlm.nih.gov
Mortality benefits from implantable cardioverter-defibrillator therapy are not restricted to patients with remote myocardial infarction: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). [2021]
A Canadian hospital's experience with the automatic implantable cardioverter/defibrillator. [2018]
15.United Statespubmed.ncbi.nlm.nih.gov
Post myocardial infarction, left ventricular dysfunction, and the expanding role of cardiac implantable electrical devices. [2019]