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High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification (STOP CP)

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ClinicalTrials.gov Identifier: NCT02984436
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
University of Florida

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.


Condition or disease Intervention/treatment
Acute Coronary Syndrome Chest Pain Procedure: Blood Sample Behavioral: HEART Score

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.


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Study Type : Observational
Actual Enrollment : 1572 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Chest Pain

Group/Cohort Intervention/treatment
ED Patients with Acute Chest Pain
Emergency Department (ED) Patients with Acute Chest Pain will have blood samples collected for High sensitivity cardiac troponin T (hs-CTnT) analysis. Results from this analysis will be integrated into the HEART Score/Pathway. It will later be seen if integration of the hs-cTnT outperforms the use of HEART Score/Pathway alone.
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.
Other Name: Blood draw

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.
Other Name: HEART Pathway




Primary Outcome Measures :
  1. High Sensitivity Cardiac Troponin T using lithium heparin tubes [ Time Frame: Baseline ]
    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. High Sensitivity Cardiac Troponin T using lithium heparin tubes [ Time Frame: 1 hour after baseline ]
    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. High Sensitivity Cardiac Troponin T using lithium heparin tubes [ Time Frame: 2 hours after baseline ]
    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.

  4. High Sensitivity Cardiac Troponin T using lithium heparin tubes [ Time Frame: 3 hours after baseline ]
    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.

  5. High Sensitivity Cardiac Troponin T using EDTA tubes [ Time Frame: Baseline ]
    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.

  6. High Sensitivity Cardiac Troponin T using EDTA tubes [ Time Frame: 1 hour after baseline ]
    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.

  7. High Sensitivity Cardiac Troponin T using EDTA tubes [ Time Frame: 2 hours after baseline ]
    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.

  8. High Sensitivity Cardiac Troponin T using EDTA tubes [ Time Frame: 3 hours after baseline ]
    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.

  9. Cardiac Troponin T (cTn) [ Time Frame: Baseline ]
    Site-specific cTn will be measured at baseline

  10. Cardiac Troponin T (cTn) [ Time Frame: 3 hours ]
    Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive

  11. Occurrence of major adverse cardiac events (MACE) [ Time Frame: 30 days ]
  12. Occurrence of major adverse cardiac events (MACE) [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. HEART Score Calculation [ Time Frame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge ]
    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

  2. Incidence and Intensity of Adverse Events [ Time Frame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge ]
    Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984436


Locations
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United States, California
UC Davis
Sacramento, California, United States, 95817
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Florida
Roche Diagnostics
Investigators
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Principal Investigator: Brandon R Allen, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02984436     History of Changes
Other Study ID Numbers: STOP CP
OCR15652 ( Other Identifier: University of Florida )
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Chest Pain
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms