Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

NCT ID: NCT03129659

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome Chest Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CT-group

Coronary CT angiography

Group Type EXPERIMENTAL

Coronary CT Angiography

Intervention Type DIAGNOSTIC_TEST

Coronary CT angiography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coronary CT Angiography

Coronary CT angiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Admir Dedic

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amphia ziekenhuis

Breda, North Brabant, Netherlands

Site Status RECRUITING

Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Admir Dedic, PhD

Role: CONTACT

+31107034994

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jeroen Schaap, MD, PhD

Role: primary

Admir Dedic, MD,PhD

Role: primary

0107040704

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39150488 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34663657 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COURSE-11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.