Heart AttackMAPS-IIINCT05957172
Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation
An observational study of Heart Attack and Cardiac Event, run by Zoll Medical Corporation.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Heart Attack, Cardiac Event, Cardiac Disease
- What is being tested?
- ZOLL Arrhythmia Management System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post-MI patients with an EF >35% undergoing cardiac rehabilitation
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Heart Attack, Cardiac Event, Cardiac Disease, Cardiac Infarct, NSTEMI, STEMI
- Being tested
- ZOLL Arrhythmia Management System
- Keywords
- heart attack, myocardial infarction, STEMI, NSTEMI
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOLL Arrhythmia Management SystemDevice
Also called AMS
AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity, and body posture (biometric data)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: ZOLL Arrhythmia Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30-60 days
Secondary outcomes (6)
AMS-derived data - Heart Rate
Improvement in nighttime resting heart rate
Measured: 30-60 days
AMS-derived data - Activity
Changes in total daily activity as detected by the AMS accelerometers
Measured: 30-60 days
AMS-derived data - Arrhythmias
Occurrence of Arrhythmias as detected by the AMS
Measured: 30-60 days
Subject reported outcomes - Beta blocker/ivabradine usage/changes
Initiation/Termination/Changes in beta blocker/ivabradine usage recorded via weekly diary
Measured: 30-60 days
Subject reported outcomes - Symptoms
Occurrence and changes in symptoms recorded via weekly diary
Measured: 30-60 days
Subject reported outcomes - Cardiovascular events
Cardiovascular events as measured by health care use i.e. unplanned health care provider visits due to cardiovascular event, recorded via weekly diary
Measured: 30-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study startJan 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957172
- Sponsor's protocol ID
- 90D0257
- Acronym
- MAPS-III
- Status last verified
- Jul 2023
- First submitted
- 23 Jan 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05957172
- Acronym / sponsor ID
- MAPS-III / 90D0257
- Conditions
- Heart Attack, Cardiac Event, Cardiac Disease, Cardiac Infarct, NSTEMI, STEMI
- Keywords
- heart attack, myocardial infarction, STEMI, NSTEMI
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Futility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | – | Device: ZOLL Arrhythmia Management SystemSubjects assigned to wear the FDA-cleared AMS device for 30-60 days Sequential enrollment to avoid preferential selection Investigator blinded to the AMS data |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-MI patients with an EF >35% undergoing cardiac rehabilitation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZOLL Arrhythmia Management SystemAlso: AMSAMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity, and body posture (biometric data) | Device | Active Treatment |
Primary outcome
Cardiac rehabilitation program referrals and completions (in-clinic or home-based)
Time frame: 30-60 days
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
6 secondary outcomes
AMS-derived data - Heart Rate
Time frame: 30-60 days
AMS-derived data - Activity
Time frame: 30-60 days
AMS-derived data - Arrhythmias
Time frame: 30-60 days
Subject reported outcomes - Beta blocker/ivabradine usage/changes
Time frame: 30-60 days
Subject reported outcomes - Symptoms
Time frame: 30-60 days
Subject reported outcomes - Cardiovascular events
Time frame: 30-60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Attack and Cardiac Event, run by Zoll Medical Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac rehabilitation program referrals and completions (in-clinic or home-based) (time frame: 30-60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.