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High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification

NCT02984436

CompletedN/A

Sponsor: University of Florida

Conditions: Acute Coronary Syndrome, Chest Pain

Interventions: Blood Sample, HEART Score

Countries: United States

This is a prospective observational cohort study of ED patients with acute chest pain or other symptoms suggestive of ACS. Blood samples will be collected from study participants for High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for research purposes only. Providers will be blinded to results and participants will be treated by their healthcare providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to ascertain study outcomes.

Eligibility overview

Sex: ALL

Age: 21 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Age greater than or equal to 21 years at the time of enrollment in the ED
2. Chest discomfort or other symptoms consistent with possible ACS in which the treating physician plans to obtain an ECG and cTn for the patient's evaluation in the ED

Exclusion Criteria:

1. New ST-segment elevation consistent with myocardial infarction
2. Evidence of shock identified by the provider at the bedside and/or the PI
3. Terminal diagnosis with life expectancy less than 90 days
4. A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission
5. Prior enrollment in the STOP CP study
6. Lack of capacity to provide consent and comply with study procedures
7. Inability to be reliably reached after the index visit for follow-up
8. Non-English speaking
9. Pregnant patients
10. Provider does not intend on obtaining serial cTn assays for evaluation of ACS
11. The first study draw (T0) will exceed 1 hour after the site-specific standard of care troponin draw
12. Unable or unwilling to authorize medical records release
Locations (6)
  • Sacramento, California, United States
  • Gainesville, Florida, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States
  • Winston-Salem, North Carolina, United States
  • Salt Lake City, Utah, United States