- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03129659
Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome (COURSE)
February 3, 2021 updated by: Admir Dedic, Erasmus Medical Center
Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Admir Dedic, PhD
- Phone Number: +31107034994
- Email: a.dedic@erasmusmc.nl
Study Locations
-
-
North Brabant
-
Breda, North Brabant, Netherlands
- Recruiting
- Amphia ziekenhuis
-
Contact:
- Jeroen Schaap, MD, PhD
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
- Recruiting
- Erasmus MC
-
Contact:
- Admir Dedic, MD,PhD
- Phone Number: 0107040704
- Email: a.dedic@erasmusmc.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CT-group
Coronary CT angiography
|
Coronary CT angiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.
Time Frame: 30 day
|
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.
Time Frame: 30 day
|
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.
Time Frame: 30 day
|
To determine which clinical characteristics are predictive of not having obstructive coronary artery disease on CT.
|
30 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
April 16, 2017
First Submitted That Met QC Criteria
April 21, 2017
First Posted (Actual)
April 26, 2017
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 3, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COURSE-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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