Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome

Not Applicable

• Conditions: Acute Coronary Syndrome; Chest Pain
• Interventions: Diagnostic Test: Coronary CT Angiography

• Registration Number: NCT03129659
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-16
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Study Start: 2018-02-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04
• Primary Completion: 2021-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT-group	Coronary CT Angiography	Coronary CT angiography

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.	30 day	Sensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS.

Secondary Outcome Measures

Name	Time	Method
Potential improvement of diagnostic accuracy with FFR-CT.	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.	30 day	To determine which clinical characteristics are predictive of not having obstructive coronary artery disease on CT.

Trial Locations

Locations (2)

Amphia ziekenhuis; 🇳🇱 Breda, North Brabant, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands