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Index Event for Cardiovascular Events

N/A
Recruiting
Research Sponsored by Beckman Coulter, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All genders, races, ethnicities
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30-days from the emergency department visit with suspicion of acs (acute coronary syndrome)
Awards & highlights

Study 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.

Eligible Conditions
  • Cardiovascular Events

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30-days from the emergency department visit with suspicion of acs (acute coronary syndrome)
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30-days from the emergency department visit with suspicion of acs (acute coronary syndrome) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity

Trial Design

1Treatment groups
Experimental Treatment
Group I: Index EventExperimental Treatment1 Intervention
Patients with at least one Beckman High Sensitivity Troponin test at the Emergency Department visit

Find a Location

Who is running the clinical trial?

Beckman Coulter, Inc.Lead Sponsor
33 Previous Clinical Trials
434,736 Total Patients Enrolled
Alicia DrainStudy DirectorBeckman Coulter

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MACE CDS Software Master Enrollment Protocol
2023. "MACE CDS Software Master Enrollment Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06257628.
All > Paid Studies Baltimore > Cincinnati
~2545 spots leftby Nov 2024
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