NCT05957172

Brief Summary

Advanced remote multi-parameter reporting during cardiac rehabilitation (MAPS-III). The primary purpose of this observational study is to collect baseline information of cardiac rehabilitation usage in the US for post-myocardial infarction (MI) patients with EF \> 35% while wearing the ZOLL AMS device for 30 to 60 days. Secondary data on biometrics, arrhythmias, symptoms, and healthcare utilization will provide additional background information on this population during the early post-MI cardiac rehabilitation period.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

January 23, 2023

Last Update Submit

July 13, 2023

Conditions

Heart AttackCardiac EventCardiac DiseaseCardiac InfarctNSTEMISTEMI

Keywords

heart attackmyocardial infarctionSTEMINSTEMI

Outcome Measures

Primary Outcomes (1)

  • Cardiac rehabilitation program referrals and completions (in-clinic or home-based)

    Measure the completion rate of patients undergoing cardiac rehabilitation programs i.e. the number of cardiac rehabilitation program referrals vs. number of cardiac rehabilitation program completions

    30-60 days

Secondary Outcomes (6)

  • AMS-derived data - Heart Rate

    30-60 days

  • AMS-derived data - Activity

    30-60 days

  • AMS-derived data - Arrhythmias

    30-60 days

  • Subject reported outcomes - Beta blocker/ivabradine usage/changes

    30-60 days

  • Subject reported outcomes - Symptoms

    30-60 days

  • +1 more secondary outcomes

Study Arms (1)

Active Treatment

Subjects assigned to wear the FDA-cleared AMS device for 30-60 days Sequential enrollment to avoid preferential selection Investigator blinded to the AMS data

Device: ZOLL Arrhythmia Management System

Interventions

ZOLL Arrhythmia Management SystemDEVICE

AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity, and body posture (biometric data)

Also known as: AMS
Active Treatment

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Post-MI patients with an EF \>35% undergoing cardiac rehabilitation

You may qualify if:

  • Both male and female subjects who are between 21 - 75 years of age, inclusively
  • Subjects who are consented and enrolled into the study prior to discharge from the qualifying acute myocardial infarction
  • Subjects with a consistent EF \>35% post the qualifying acute myocardial infarction

You may not qualify if:

  • Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, an implanted cardioverter defibrillator (ICD), a cardiac resynchronization therapy device, subcutaneous ICDs, pressure monitors, and loop monitors.
  • Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time.
  • Subjects with a skin condition preventing them from wearing the AMS device.
  • Subjects who are non-ambulatory for any reason.
  • Subjects who are self-reporting to be pregnant.
  • Subjects with comorbidities that would preclude adherence to a cardiac rehabilitation program - at the discretion of the physician.
  • Subjects participating or planning to participate in another interventional study during the protocol-defined study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial InfarctionCardiovascular DiseasesHeart DiseasesNon-ST Elevated Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

July 24, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

October 1, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07