Clinical trial NCT02984436: High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
Official title: High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Chest Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2016-12-07
Enrollment: 1572
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients 21 years of age or older with possible Acute Coronary Syndrome (ACS) and associated chest pain.

Brief summary: 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.

Detailed description: Approximately 8 million - 10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. To avoid missing the diagnosis of acute coronary syndrome (ACS), physicians use a liberal testing strategy. Thus, \>50% of ED patients with acute chest pain are hospitalized for a comprehensive cardiac evaluation (serial cardiac biomarkers and stress testing or angiography). However, \<10% of these patients are ultimately diagnosed with ACS, and this pervasive over-triage costs an estimated $10 billion - $13 billion annually. Current care patterns for acute chest pain fail to focus health system resources, such as hospitalization and stress testing, on patients most likely to benefit.

It has demonstrated that an accelerated diagnostic protocol (ADP), called the HEART Pathway, which utilizes a clinical decision aid (the HEART score) and serial Cardiac Troponin (cTn) measures are sensitive for ACS (\>99%) and can substantially reduce hospitalizations, stress testing, and cost compared to usual care. The HEART Pathway uses contemporary serial cTn measurements at 0 and 3 hours to exclude index myocardial infarction (MI) and relies on clinical features (history, ECG, age, and risk factors) to identify patients likely to have downstream events. However, the HEART Pathway has limitations: a) It identifies only 20 - 40% of patients for early discharge and b) it was developed before high-sensitivity cTn assays became available. Able to detect MI earlier and with greater accuracy than contemporary assays, hs-cTn assays have the potential to be integrated into decision aids to improve chest pain risk stratification. In the near future, hs-cTn assays will replace contemporary assays in the United States.

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

Primary outcomes:
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
timeFrame: Baseline
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
timeFrame: 1 hour after baseline
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
timeFrame: 2 hours after baseline
measure: High Sensitivity Cardiac Troponin T using lithium heparin tubes
timeFrame: 3 hours after baseline
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
timeFrame: Baseline
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
timeFrame: 1 hour after baseline
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
timeFrame: 2 hours after baseline
measure: High Sensitivity Cardiac Troponin T using EDTA tubes
timeFrame: 3 hours after baseline
measure: Cardiac Troponin T (cTn)
timeFrame: Baseline
measure: Cardiac Troponin T (cTn)
timeFrame: 3 hours
measure: Occurrence of major adverse cardiac events (MACE)
timeFrame: 30 days
measure: Occurrence of major adverse cardiac events (MACE)
timeFrame: 90 days
Secondary outcomes:
measure: HEART Score Calculation
timeFrame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
measure: Incidence and Intensity of Adverse Events
timeFrame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Florida
name: Brandon R Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen BR, Christenson RH, Cohen SA, Nowak R, Wilkerson RG, Mumma B, Madsen T, McCord J, Huis In't Veld M, Massoomi M, Stopyra JP, Montero C, Weaver MT, Yang K, Mahler SA. Diagnostic Performance of High-Sensitivity Cardiac Troponin T Strategies and Clinical Variables in a Multisite US Cohort. Circulation. 2021 Apr 27;143(17):1659-1672. doi: 10.1161/CIRCULATIONAHA.120.049298. Epub 2021 Jan 21.