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

Primary Purpose

Acute Coronary Syndrome, Chest Pain

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Coronary CT Angiography
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Coronary CT Angiography, High-sensitivity Troponin, Diagnosis

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Amphia ziekenhuisRecruiting
  • Erasmus MCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT-group

Arm Description

Coronary CT angiography

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 16, 2017
Last Updated
February 3, 2021
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03129659
Brief Title
Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome
Acronym
COURSE
Official Title
Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Chest Pain
Keywords
Coronary CT Angiography, High-sensitivity Troponin, Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-group
Arm Type
Experimental
Arm Description
Coronary CT angiography
Intervention Type
Diagnostic Test
Intervention Name(s)
Coronary CT Angiography
Intervention Description
Coronary CT angiography
Primary Outcome Measure Information:
Title
Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.
Description
Sensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS.
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Potential improvement of diagnostic accuracy with FFR-CT.
Description
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.
Time Frame
30 day
Title
Clinical characteristics of no obstructive coronary artery disease on CT.
Description
To determine which clinical characteristics are predictive of not having obstructive coronary artery disease on CT.
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Admir Dedic, PhD
Phone
+31107034994
Email
a.dedic@erasmusmc.nl
Facility Information:
Facility Name
Amphia ziekenhuis
City
Breda
State/Province
North Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Schaap, MD, PhD
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 CE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Admir Dedic, MD,PhD
Phone
0107040704
Email
a.dedic@erasmusmc.nl

12. IPD Sharing Statement

Citations:
PubMed Identifier
34663657
Citation
Arslan 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.
Results Reference
derived

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Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

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