Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— COURSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129659
• Other study ID #: COURSE-11
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2021
• Source: Erasmus Medical Center
• Contact: Admir Dedic, PhD
• Phone: +31107034994
• Email: a.dedic[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Syndrome

Intervention

Diagnostic Test:
• Coronary CT Angiography
Coronary CT angiography

Locations

Country	Name	City	State
Netherlands	Amphia ziekenhuis	Breda	North Brabant
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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