Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

Overview

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.

Full Title of Study: “Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2021

Interventions

  • Diagnostic Test: Coronary CT Angiography
    • Coronary CT angiography

Arms, Groups and Cohorts

  • Experimental: CT-group
    • Coronary CT angiography

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasmus Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Admir Dedic, Principal Investigator – Erasmus Medical Center
  • Overall Contact(s)
    • Admir Dedic, PhD, +31107034994, a.dedic@erasmusmc.nl

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