Arrhythmia Detection After MI

ConditionAcute Myocardial Infarction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSamir Saba

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Standard of Care
Other intervention
Routine monitoring of post AMI patient with clinic visits
ICM Implantation
Device
Implantation of ICM through small incision (2 mm) under the skin

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: ControlActive comparator 1 intervention

Group B: ICMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Changes to patient management

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

Time frame

90 days post AMI

Time to diagnosis and/or treatment of cardiac arrhythmia

days post randomization

Time frame

90 days post AMI

Secondary outcomes

Changes to patient management

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

Time frame

24 months

Mortality

all-cause mortality

Time frame

at 90 days

Mortality

All-cause mortality

Time frame

at 24 months

Other outcomes

Depression and Anxiety Scale

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

Time frame

at 90 days

Depression and Anxiety Scale

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

Time frame

at 24 months

Physical and Mental Health

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

Time frame

at 90 days

Physical and Mental Health

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

Time frame

at 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samir Saba

Lead sponsor

University of Pittsburgh

Sponsor institution

Abbott

Collaborator

Source ClinicalTrials.gov

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