High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy. Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).

Official Title
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High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study

Conditions
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Chest Pain, Acute Coronary Syndrome

Intervention / Treatment
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* Other: Fast strategy
* Other: Standard of care strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chest pain consistent with possible acute coronary syndrome. Age > 18 years. Informed consent. Exclusion Criteria: Previous history of coronary artery disease. Electrocardiogram diagnostic or suggestive of myocardial ischemia. Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias). Chronic kidney disease (GFR <30 mL/min/1,73 m2). Iodine contrast allergy. Incapability to perform treadmill stress test. Barthel activity of daily living scale index < 100.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast strategy<br>High sensitivity cardiac troponin T followed by computed coronary tomography angiography | Other: Fast strategy<br>* High sensitivity troponin T followed by computed coronary tomography angiography<br>|
| Active Comparator: Standard of care strategy<br>Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study | Other: Standard of care strategy<br>* Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department | Composite end-point. | 1 month after index event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 1 month | 
| Myocardial infarction |  | 1 month | 
| Unstable angina |  | 1 month | 
| Heart Failure |  | 1 month | 
| Hospital admission | New cardiovascular hospital admission | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest pain, Acute coronary syndrome, Cardiac biomarkers, Computed coronary tomography angiography, Emergency department