Acute Coronary SyndromeCOURSENCT03129659
Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome
A study testing Coronary CT Angiography in people with Acute Coronary Syndrome and Chest Pain, run by Erasmus Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain
- What is being tested?
- Coronary CT Angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Feb 2018to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Amphia ziekenhuis
Breda, North Brabant
Jeroen Schaap, MD, PhD
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 CE
Admir Dedic, MD,PhD, 0107040704, a.dedic@erasmusmc.nl
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Being tested
- Coronary CT Angiography
- Keywords
- Coronary CT Angiography, High-sensitivity Troponin, Diagnosis
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT AngiographyDiagnostic test
Coronary CT angiography
| Study group | Role | What they receive |
|---|---|---|
| CT-group | Experimental | Coronary CT angiography Receives: Diagnostic Test: Coronary CT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 day
Secondary outcomes (2)
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.
Measured: 30 day
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.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Feb 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Admir Dedic, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129659
- Sponsor's protocol ID
- COURSE-11
- Acronym
- COURSE
- Status last verified
- Feb 2021
- First submitted
- 16 Apr 2017
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arslan M, Schaap J, van Gorsel B, Aubanell A, Budde RPJ, Hirsch A, Smulders MW, Mihl C, Damman P, Sliwicka O, Habets J, Dubois EA, Dedic A. Coronary computed tomography angiography improves assessment of patients with acute chest pain and inconclusively elevated high-sensitivity troponins. Eur Radiol. 2025 Feb;35(2):789-797. doi: 10.1007/s00330-024-10930-1. Epub 2024 Aug 16.
PubMed 39150488Arslan M, Schaap J, Van Gorsel B, Budde RP, Bekkers SC, Van Cauteren YJ, Damman P, Habets J, Dubois EA, Dedic A. Coronary CT angiography for improved assessment of patients with acute chest pain and low-range positive high-sensitivity troponins: study protocol for a prospective, observational, multicentre study (COURSE trial). BMJ Open. 2021 Oct 18;11(10):e049349. doi: 10.1136/bmjopen-2021-049349.
PubMed 34663657
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up
- ClinicalTrials.gov ID
- NCT03129659
- Acronym / sponsor ID
- COURSE / COURSE-11
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Keywords
- Coronary CT Angiography, High-sensitivity Troponin, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-group | Experimental | Diagnostic Test: Coronary CT AngiographyCoronary CT angiography |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT AngiographyCoronary CT angiography | Diagnostic test | CT-group |
Primary outcome
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.
2 secondary outcomes
Potential improvement of diagnostic accuracy with FFR-CT.
Time frame: 30 day
Clinical characteristics of no obstructive coronary artery disease on CT.
Time frame: 30 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 39150488Arslan M, Schaap J, van Gorsel B, Aubanell A, Budde RPJ, Hirsch A, Smulders MW, Mihl C, Damman P, Sliwicka O, Habets J, Dubois EA, Dedic A. Coronary computed tomography angiography improves assessment of patients with acute chest pain and inconclusively elevated high-sensitivity troponins. Eur Radiol. 2025 Feb;35(2):789-797. doi: 10.1007/s00330-024-10930-1. Epub 2024 Aug 16.
- Derived from this study: PubMed 34663657Arslan M, Schaap J, Van Gorsel B, Budde RP, Bekkers SC, Van Cauteren YJ, Damman P, Habets J, Dubois EA, Dedic A. Coronary CT angiography for improved assessment of patients with acute chest pain and low-range positive high-sensitivity troponins: study protocol for a prospective, observational, multicentre study (COURSE trial). BMJ Open. 2021 Oct 18;11(10):e049349. doi: 10.1136/bmjopen-2021-049349.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary CT Angiography in people with Acute Coronary Syndrome and Chest Pain, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Admir Dedic, PhD (+31107034994, a.dedic@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS. (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03129659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.