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

Acute Coronary Syndrome Clinical Trial

— STOP CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984436
• Other study ID #: STOP CP
• Secondary ID: OCR1565220162880
• Status: Completed
• Start date: January 25, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1572
• Est. completion date: September 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

Procedure:
• Blood Sample
Blood samples will be collected from study participants for hs-cTnT analysis. Results of hs-cTnT will be used for research purposes only. Providers and participants will be blinded to results and participants will be treated by their healthcare providers per the standard of care.

Behavioral:
• HEART Score
The HEART Score is a prospectively studied scoring system to help emergency departments risk-stratify chest pain patients. Patients score on a scale of 0-10.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Roche Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Sensitivity Cardiac Troponin T using lithium heparin tubes	The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	Baseline
Primary	High Sensitivity Cardiac Troponin T using lithium heparin tubes	The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	1 hour after baseline
Primary	High Sensitivity Cardiac Troponin T using lithium heparin tubes	The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	2 hours after baseline
Primary	High Sensitivity Cardiac Troponin T using lithium heparin tubes	The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	3 hours after baseline
Primary	High Sensitivity Cardiac Troponin T using EDTA tubes	The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	Baseline
Primary	High Sensitivity Cardiac Troponin T using EDTA tubes	The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	1 hour after baseline
Primary	High Sensitivity Cardiac Troponin T using EDTA tubes	The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	2 hours after baseline
Primary	High Sensitivity Cardiac Troponin T using EDTA tubes	The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.	3 hours after baseline
Primary	Cardiac Troponin T (cTn)	Site-specific cTn will be measured at baseline	Baseline
Primary	Cardiac Troponin T (cTn)	Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive	3 hours
Primary	Occurrence of major adverse cardiac events (MACE)		30 days
Primary	Occurrence of major adverse cardiac events (MACE)		90 days
Secondary	HEART Score Calculation	By assigning zero, one, or two points - towards an atypical patient history, ECG anomalies, the patient's age, any risk factors present, and elevated Troponin - patients score on a scale of 0-10. 0-3 = Low-risk, 4 or greater = High-risk	Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
Secondary	Incidence and Intensity of Adverse Events	Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0	Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge