Cardiac EventsNCT06257628
MACE CDS Software Master Enrollment Protocol
An observational study of Cardiac Events, run by Beckman Coulter, Inc. at 3 sites in United States.
Trial summary
This protocol will collect real world EHR data to support the product development life cycle activities associated with developing the Major Adverse Cardiac Events (MACE) Clinical Decision Support (CDS) software. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Cardiac Events
- What is being tested?
- Index Event
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Sep 2023to 31 May 2025
- 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 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting ED with suspicion of Acute Coronary Syndrome (ACS).
Who may be able to join
- All genders, races, ethnicities
Who cannot join
- ≤ 18 years old presenting to the ED and for clinical validation only, adults < 22 years old
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21211
Henry Ford Health System
Detroit, Michigan, 48202
Kettering Health
Kettering, Ohio, 45429
About this study
This protocol will collect real world EHR data to support the product development life cycle activities associated with developing the Major Adverse Cardiac Events (MACE) Clinical Decision Support (CDS) software.
The data will also be utilized in subsequent clinical validation to support an FDA application and/or applications to other regulatory agencies as needed.
Read the detailed description
The primary objective is to develop a machine learning tool which predicts risk of 30-day MACE (major adverse cardiac event) risk stratification among patients visiting ED with suspicion of ACS (Acute Coronary Syndrome).
The data will also be utilized in subsequent clinical validation. In addition to retrospective Electronic Health Record (EHR) data, Health Information Exchange (HIE) data and patient reported outcomes will be collected to capture 30-day MACE outcomes, as applicable.
- Conditions
- Cardiac Events
- Being tested
- Index Event
- Keywords
- Emergency Department, Major Adverse Cardiac Events
- Medical subject headings
- Cardiovascular Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index EventDevice
Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit
| Study group | Role | What they receive |
|---|---|---|
| Index Event | Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit Receives: Device: Index Event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity
Clinical performance of MACE (Major Adverse Cardiac Events) CDS (Clinical Decision Support) tool to identify a patient's risk of for having a MACE (Major Adverse Cardiac Events) within 30 days, with both a single High-Sensitive Troponin and a second High-Sensitive Troponin (if applicable).
Measured: Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start14 Sep 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EventsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia Drain, Study director, Beckman Coulter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257628
- Sponsor's protocol ID
- 2.7.2.1
- Status last verified
- Nov 2025
- First submitted
- 18 Oct 2023
- Last updated
- 12 Nov 2025
- 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 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MACE CDS Software Master Enrollment Protocol
- ClinicalTrials.gov ID
- NCT06257628
- Acronym / sponsor ID
- 2.7.2.1
- Conditions
- Cardiac Events
- Keywords
- Emergency Department, Major Adverse Cardiac Events
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 14 Feb 2024 (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.
This protocol will collect real world EHR data to support the product development life cycle activities associated with developing the Major Adverse Cardiac Events (MACE) Clinical Decision Support (CDS) software.
The data will also be utilized in subsequent clinical validation to support an FDA application and/or applications to other regulatory agencies as needed.
Detailed description
The primary objective is to develop a machine learning tool which predicts risk of 30-day MACE (major adverse cardiac event) risk stratification among patients visiting ED with suspicion of ACS (Acute Coronary Syndrome).
The data will also be utilized in subsequent clinical validation. In addition to retrospective Electronic Health Record (EHR) data, Health Information Exchange (HIE) data and patient reported outcomes will be collected to capture 30-day MACE outcomes, as applicable.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Index Event | – | Device: Index EventPatients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting ED with suspicion of Acute Coronary Syndrome (ACS).
Key inclusion criteria (1 listed)
- All genders, races, ethnicities
Key exclusion criteria (1 listed)
- ≤ 18 years old presenting to the ED and for clinical validation only, adults < 22 years old
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 |
|---|---|---|
| Index EventPatients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit | Device | Index Event |
Primary outcome
Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity
Time frame: Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome)
Clinical performance of MACE (Major Adverse Cardiac Events) CDS (Clinical Decision Support) tool to identify a patient's risk of for having a MACE (Major Adverse Cardiac Events) within 30 days, with both a single High-Sensitive Troponin and a second High-Sensitive Troponin (if applicable).
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 12 Nov 2025.
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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.
Alicia Drain study director
Beckman Coulter
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Events, run by Beckman Coulter, Inc. at 3 sites in United States.
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 1 inclusion and 1 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 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity (time frame: Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome)). 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 12 Nov 2025.