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Trial record 8 of 9 for:    Recruiting, Not yet recruiting, Available Studies | Allergy CT

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

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ClinicalTrials.gov Identifier: NCT03129659
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Admir Dedic, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Chest Pain Diagnostic Test: Coronary CT Angiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arm Intervention/treatment
Experimental: CT-group
Coronary CT angiography
Diagnostic Test: Coronary CT Angiography
Coronary CT angiography




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129659


Contacts
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Contact: Admir Dedic, PhD +31107034994 a.dedic@erasmusmc.nl

Locations
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Netherlands
Amphia ziekenhuis Recruiting
Breda, North Brabant, Netherlands
Contact: Jeroen Schaap, MD, PhD         
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: Admir Dedic, MD,PhD    0107040704    a.dedic@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center

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Responsible Party: Admir Dedic, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03129659     History of Changes
Other Study ID Numbers: COURSE-11
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Admir Dedic, Erasmus Medical Center:
Coronary CT Angiography
High-sensitivity Troponin
Diagnosis
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Chest Pain
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms