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Trial record 1 of 4 for:    Arrhythmia Detection After MI
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Arrhythmia Detection After MI (AID MI)

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ClinicalTrials.gov Identifier: NCT05073419
Recruitment Status : Recruiting
First Posted : October 11, 2021
Last Update Posted : October 10, 2022
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Samir Saba, University of Pittsburgh

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Other: Standard of Care Device: ICM Implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Clinical information regarding ICM implantation will be withheld from outcome assessors
Primary Purpose: Treatment
Official Title: Arrhythmia Detection After Myocardial Infarction Trial
Actual Study Start Date : August 9, 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Post-AMI patients in this arm will receive standard of care
Other: Standard of Care
Routine monitoring of post AMI patient with clinic visits
Other Name: Control

Experimental: ICM
Post-AMI patients in this arm will receive standard of care and an ICM
Device: ICM Implantation
Implantation of ICM through small incision (2 mm) under the skin
Other Name: ICM




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05073419


Contacts
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Contact: Samir F Saba, MD 412 647 2695 sabas@upmc.edu
Contact: Melissa Enlow 412-647-1582 enlowms@upmc.edu

Locations
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United States, Pennsylvania
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Eric Pasquantonio    412-647-8210    pasquantonioej@upmc.edu   
Sponsors and Collaborators
Samir Saba
Abbott
Investigators
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Principal Investigator: Samir F Saba, MD University of Pittsburgh Medical Center
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Responsible Party: Samir Saba, Division Chief of Cardiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT05073419    
Other Study ID Numbers: STUDY21060027
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication of protocol, methods, results in aggregates
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 1 year after publication of the mainmanuscript
Access Criteria: Submit request to PI Only de-identified data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases