Development of software to predict major cardiac events in emergency patients
MACE CDS Software Master Enrollment Protocol
This study is testing new software that helps doctors predict the risk of serious heart problems in emergency patients who might have heart issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5515 (estimated) |
| Ages | 23 Years and up |
| Sex | All |
| Sponsor | Beckman Coulter, Inc. Industry-sponsored |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT06257628 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect real-world electronic health record (EHR) data to support the development of a Clinical Decision Support (CDS) software that predicts the risk of major adverse cardiac events (MACE) in patients visiting the emergency department with suspected acute coronary syndrome. The study will utilize retrospective EHR data, health information exchange data, and patient-reported outcomes to assess 30-day MACE outcomes. The ultimate goal is to validate the software for potential regulatory approval.
Who should consider this trial
Good fit: Ideal candidates for this study are adults presenting to the emergency department with suspicion of acute coronary syndrome.
Not a fit: Patients under 18 years old or those presenting with conditions unrelated to cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this software could significantly improve the early identification and management of patients at risk for major cardiac events.
How similar studies have performed: Other studies have shown promise in using machine learning for cardiac risk stratification, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All genders, races, ethnicities Exclusion Criteria: * ≤ 18 years old presenting to the ED and for clinical validation only, adults \< 22 years old
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins University — Baltimore, Maryland, United States (Not_yet_recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- Kettering Health — Kettering, Ohio, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Alicia Drain
- Email: adrain@beckman.com
- Phone: 512-906-8763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.