Clinical trial NCT05957172: Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation
Official title: Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Attack
Cardiac Event
Cardiac Disease
Cardiac Infarct
NSTEMI
STEMI
Keywords: heart attack
myocardial infarction
STEMI
NSTEMI
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-MI patients with an EF \>35% undergoing cardiac rehabilitation

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.

Detailed description: To collect baseline data on cardiac rehabilitation usage (referrals and completion) in recent post-MI patients with EF \> 35%.To collect data on AMS-derived biometric data (e.g. HR, activity) and arrhythmias, and subject-reported symptoms, beta blocker/ivabradine usage (dose/changes) and cardiovascular events. The participating centers will enroll consenting subjects in a sequential manner to avoid preferential selection of patients to participate in the study. Subjects will be consented by the center study staff, and if eligible will wear the FDA-cleared AMS device for 30-60 days. Subject demographic information and clinical history will be obtained at the time of enrollment. During the study period, the prescribing physician-investigator will be blinded to AMS data. Final subject follow-up will be at 3 months. A sample size of 150 subjects is estimated in order to have 100 subjects with at least 30 days of AMS use for analysis.

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time.
3. Subjects with a skin condition preventing them from wearing the AMS device.
4. Subjects who are non-ambulatory for any reason.
5. Subjects who are self-reporting to be pregnant.
6. Subjects with comorbidities that would preclude adherence to a cardiac rehabilitation program - at the discretion of the physician.
7. Subjects participating or planning to participate in another interventional study during the protocol-defined study period

Primary outcomes:
measure: Cardiac rehabilitation program referrals and completions (in-clinic or home-based)
timeFrame: 30-60 days
Secondary outcomes:
measure: AMS-derived data - Heart Rate
timeFrame: 30-60 days
measure: AMS-derived data - Activity
timeFrame: 30-60 days
measure: AMS-derived data - Arrhythmias
timeFrame: 30-60 days
measure: Subject reported outcomes - Beta blocker/ivabradine usage/changes
timeFrame: 30-60 days
measure: Subject reported outcomes - Symptoms
timeFrame: 30-60 days
measure: Subject reported outcomes - Cardiovascular events
timeFrame: 30-60 days
Other outcomes:
Locations:
Study officials:
References: