WithdrawnNot Applicable

MACE CDS Software Master Enrollment Protocol

Stopped: Business decision

United States0Started 2023-09-14

Plain-language 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. The data will also be utilized in subsequent clinical validation to support an FDA application and/or applications to other regulatory agencies as needed.

Who can participate

Age range23 Years

SexALL

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Inclusion Criteria: * All genders, races, ethnicities Exclusion Criteria: * ≤ 18 years old presenting to the ED and for clinical validation only, adults \< 22 years old

What they're measuring

Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity

Timeframe: Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome)

Trial details

NCT IDNCT06257628

SponsorBeckman Coulter, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Cardiac Events trials