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Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03129659
Acronym
COURSE
Enrollment
230
Registered
2017-04-26
Start date
2018-02-01
Completion date
2022-09-01
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Chest Pain

Keywords

Coronary CT Angiography, High-sensitivity Troponin, Diagnosis

Brief summary

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.

Interventions

Coronary CT angiography

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.30 daySensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS.

Secondary

MeasureTime frameDescription
Potential improvement of diagnostic accuracy with FFR-CT.30 dayOff-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.
Clinical characteristics of no obstructive coronary artery disease on CT.30 dayTo determine which clinical characteristics are predictive of not having obstructive coronary artery disease on CT.

Countries

Netherlands

Contacts

Primary ContactAdmir Dedic, PhD
a.dedic@erasmusmc.nl+31107034994

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026