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ICM Implantation for Heart Attack (AID MI Trial)

N/A
Recruiting
Led By Samir F Saba, MD
Research Sponsored by Samir Saba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AMI (STEMI and NSTEMI)
Be older than 18 years old
Must not have
Planned ICD implant, planned CABG or any open-heart surgery (e.g. for severe valvular disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trialwill investigate if an implantable cardiac monitor can help reduce mortality in people after a heart attack.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risk, allergic reaction to device materials, or interference with device function leading to inaccurate monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a heart attack.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for a heart device implant or open-heart surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiac Arrhythmia
Secondary study objectives
Changes to patient management
Mortality
Other study objectives
Depression and Anxiety Scale
Physical and Mental Health

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ICM Implantation
2008
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

Samir SabaLead Sponsor
3 Previous Clinical Trials
301 Total Patients Enrolled
AbbottIndustry Sponsor
753 Previous Clinical Trials
479,035 Total Patients Enrolled
Samir F Saba, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
1 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

ICM Clinical Trial Eligibility Overview. Trial Name: NCT05073419 — N/A
Heart Attack Research Study Groups: ICM, Control
Heart Attack Clinical Trial 2023: ICM Highlights & Side Effects. Trial Name: NCT05073419 — N/A
ICM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073419 — N/A
~54 spots leftby Oct 2025
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