Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

Study Overview
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Brief Summary
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Current evaluation of patients suspected of non-ST-elevation acute coronary syndrome is greatly dictated by the results of high-sensitivity troponins. In a substantial number of patients this approach does not provide a conclusive work-up. Patients typically present with slightly elevated high-sensitivity troponins without significant changes during serial sampling and no other clinical clues that can aid in determining the etiology of their chest pain complaints. Uncertainty remains about the optimal diagnostic management of these patients and they are often admitted to undergo invasive angiography. Coronary CT angiography can improve efficiency of clinical care in these patients by reducing unnecessary hospital admissions and invasive angiography. In this study, the investigators will investigate whether a diagnostic strategy comprising of early coronary CT angiography is more clinically efficient than standard optimal care in patients with an inconclusive work-up for non-ST-elevation acute coronary syndrome.

Official Title
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Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up

Conditions
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Acute Coronary Syndrome, Chest Pain

Intervention / Treatment
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* Diagnostic Test: Coronary CT Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting to the emergency department with symptoms suggestive of NSTE-ACS. They do not fulfil criteria for either rule-in or rule-out NSTE-ACS based on serial sampling of high-sensitivity troponins and standard clinical work-up. Exclusion Criteria: Inability or unwillingness to provide informed consent. History of proven CAD, defined as documented prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery. Previous examination with either invasive angiography or CCTA in the last 3 years. Clinical instability: clinical heart failure, hemodynamic instability, severe chest pain. CCTA-specific contra-indications: Allergy to iodine contrast media Pregnancy Impaired renal function: estimated glomerular filtering rate <60% of the age-corrected normal values Severe arrhythmia likely to affect image interpretation BMI > 40 Inability to cooperate during the examination.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-group<br>Coronary CT angiography | Diagnostic Test: Coronary CT Angiography<br>* Coronary CT angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS. | Sensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS. | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential improvement of diagnostic accuracy with FFR-CT. | Off-line calculation of FFR-CT will be performed and the diagnostic accuracy for NSTE-ACS will be determined and compared to conventional coronary CT angiography. | 30 day | 
| Clinical characteristics of no obstructive coronary artery disease on CT. | To determine which clinical characteristics are predictive of not having obstructive coronary artery disease on CT. | 30 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary CT Angiography, High-sensitivity Troponin, Diagnosis