Clinical trial NCT03129659: Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome
Official title: Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Chest Pain
Keywords: Coronary CT Angiography
High-sensitivity Troponin
Diagnosis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 230
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.
timeFrame: 30 day
Secondary outcomes:
measure: Potential improvement of diagnostic accuracy with FFR-CT.
timeFrame: 30 day
measure: Clinical characteristics of no obstructive coronary artery disease on CT.
timeFrame: 30 day
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
state: North Brabant
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References:
citation: 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.