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Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome (COURSE)

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Erasmus University

Status

Unknown

Conditions

Acute Coronary Syndrome
Chest Pain

Treatments

Diagnostic Test: Coronary CT Angiography

Study type

Interventional

Funder types

Other

Identifiers

NCT03129659
COURSE-11

Details and patient eligibility

About

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.

Enrollment

230 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

230 participants in 1 patient group

CT-group
Experimental group
Description:
Coronary CT angiography
Treatment:
Diagnostic Test: Coronary CT Angiography

Trial contacts and locations

2

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Central trial contact

Admir Dedic, PhD

Data sourced from clinicaltrials.gov

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