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

Completed

Conditions studied: Acute Coronary Syndrome, Chest Pain

In brief

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.

Key facts

Study ID

NCT02984436

Run by

University of Florida

People needed

1572

Starts

2017-01-25

Expected to finish

2020-09-30

Last updated by the study team

2020-12-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 21 years at the time of enrollment in the ED
• 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

You may not qualify if…

• New ST-segment elevation consistent with myocardial infarction
• Evidence of shock identified by the provider at the bedside and/or the PI
• Terminal diagnosis with life expectancy less than 90 days
• A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission
• Prior enrollment in the STOP CP study
• Lack of capacity to provide consent and comply with study procedures
• Inability to be reliably reached after the index visit for follow-up
• Non-English speaking
• Pregnant patients
• Provider does not intend on obtaining serial cTn assays for evaluation of ACS
• The first study draw (T0) will exceed 1 hour after the site-specific standard of care troponin draw
• Unable or unwilling to authorize medical records release

Where it is running

• UC Davis — Sacramento, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Maryland — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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