ACTIVE_NOT_RECRUITING

Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department

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Conditions

ACS (Acute Coronary Syndrome)chest painmyocardial infarctionEmergency Department

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this proposal is to improve the quality and value of care for patients with acute chest pain by investigating the potential impact of point-of-care (POC) high sensitivity cardiac troponin (hs-cTn) testing in the Emergency Department (ED) and exploring how best to integrate POC hs-cTnl into ED risk stratification workflows. The study hypothesizes that the Abbott i-STAT POC hs-cTnI assay will decrease time-to-result (TTR) and ED length of stay (LOS), while increasing ED revenue for patients with acute chest pain compared to a strategy of central laboratory hs-cTnI testing.

Official Title

Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department

Quick Facts

Study Start:2025-02-07
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06899776

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to18 years
  2. * Symptoms suggestive of acute coronary syndrome:
  3. * Acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without apparent non-cardiac source
  4. * Shortness of breath, nausea, vomiting, fatigue/malaise, or
  5. * Other equivalent discomfort suggestive of an myocardial infarction (MI)
  6. * Electrocardiogram (ECG) ordered as part of standard of care
  7. * At least one troponin collected as standard of care
  8. * Study specific blood sample collected within ± 5 minutes of clinical draw
  1. * ST-segment elevation myocardial infarction (STEMI) Activation
  2. * Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic \< 90 mm Hg), tachycardia (HR\>120), bradycardia (HR\<40), and hypoxemia (\<90% pulse-oximetry on room air or normal home oxygen flow rate)
  3. * Central laboratory hs-cTn testing resulted or in process (\>5 minutes) prior to study accrual
  4. * Prior enrollment
  5. * Terminal diagnosis with life expectancy less than 6 months

Contacts and Locations

Principal Investigator

Simon Mahler, MD, MS
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
High Point Medical Center
High Point, North Carolina, 27262
United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27517
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Simon Mahler, MD, MS, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-07
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-02-07
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • chest pain
  • myocardial infarction
  • Emergency Department

Additional Relevant MeSH Terms

  • ACS (Acute Coronary Syndrome)