Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

NCT03129659 | Unknown

• 1 other identifier: COURSE-11
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome; Chest Pain

Keywords

Coronary CT Angiography; High-sensitivity Troponin; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  30 day

Secondary Outcomes (2)

• Potential improvement of diagnostic accuracy with FFR-CT.

  30 day

• Clinical characteristics of no obstructive coronary artery disease on CT.

  30 day

Study Arms (1)

CT-group

EXPERIMENTAL

Coronary CT angiography

Diagnostic Test: Coronary CT Angiography

Interventions

Coronary CT Angiography DIAGNOSTIC_TEST

Coronary CT angiography

CT-group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (2)

Amphia ziekenhuis

Breda, North Brabant, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 CE, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 39150488 DERIVED

• 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.

  PMID: 34663657 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Admir Dedic, PhD

CONTACT

+31107034994; a.dedic@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 26, 2017
• Study Start: February 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

NL (2)