Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients

Study Overview
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Brief Summary
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This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.

Official Title
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A Randomized Controlled Trial of Early Coronary Calcium Scoring and Standard Care in Emergency Department Chest Pain Patients

Conditions
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Chest Pain

Intervention / Treatment
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* Device: Coronary Calcium Scoring
* Procedure: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: complaint of chest pain or pressure intermediate risk by HEART score clinical indication for non-invasive cardiac imaging free of known coronary artery disease Exclusion Criteria: hemodynamic instability electrocardiogram suggestive of acute ischemia or myocardial infarction unremitting chest pain serum troponin levels greater than three times the laboratory threshold unable to give his/her own written, informed consent pregnant women weight > 182 kg unable to lie supine for scan coronary calcium score, coronary CTA or non-contrast thoracic CT within the last year and available for review unable to comply with 30 day follow-up

Ages Eligible for Study
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Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary Calcium Scoring<br>Coronary calcium scoring by multidetector row computed tomography (MDCT). | Device: Coronary Calcium Scoring<br>* Scan with 64-detector row or better CT scanners with quantification by the Agatston method.<br>* Other names: CCS;|
| Active Comparator: Standard Care<br>Standard evaluation of chest pain patient which often includes immediate non-invasive imaging. | Procedure: Standard Care<br>* Routine clinical monitoring of chest pain patients. Any of a number of non-invasive cardiac tests such as coronary CT angiography, stress echocardiography and stress radionuclide myocardial perfusion imaging may be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | emergency department and inpatient | through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest pain, calcium score, coronary calcium score, coronary calcium scoring, calcium scoring, cacs, ccs