The primary objective is to estimate the per patient sensitivity of combined CTCA/dynamic CTP for diagnosis of hemodynamically significant coronary artery disease with ICA/FFR as reference standard.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity of index test (CTCA and dynamic stress CTP) to diagnose
hemodynamically significant CAD with ICA with intracoronary physiology
(FFR/iFR) as reference standard.
Secondary outcome
To estimate the:
- Sensitivity and specificity for diagnosis of vulnerable coronary plaques on
CTCA with intravascular OCT as reference standard.
- Specificity of combined CTCA/dynamic CTP to diagnose hemodynamically
significant coronary artery disease on a per patient basis with ICA/FFR as
reference standard
- Sensitivity and specificity of combined CTCA/dynamic CTP to diagnose
hemodynamically significant coronary artery disease on a per vessel basis with
ICA/FFR as reference standard
- Sensitivity and specificity of mean stress blood flow (MBF) to diagnose
hemodynamically significant obstructive CAD with ICA (and FFR/iFR) as reference
standard
Background summary
Coronary CT angiography (CTCA) and myocardial CT perfusion (CTP) are
established techniques for detection of hemodynamically significant lesions in
acute and chronic coronary syndromes with negative troponins. However, in
patients with non-ST elevation myocardial infarction (NSTEMI) non-invasive
imaging has no clinical role at this moment according to the ESC guidelines.
The diagnostic pathway for these patients usually consists of invasive coronary
angiography (ICA) within 24 hours from hospital admission depending on the
GRACE risk score.
In this study, we will investigate if a combined CTCA / CTP scan could identify
hemodynamically significant obstructive coronary lesions similarly to ICA with
intracoronary physiologic flow measurement (FFR/iFR) as reference standard.
Furthermore, the detection of vulnerable coronary plaque on CTA will be
assessed with intravascular optical coherence tomography (OCT) as reference
standard.
Study objective
The primary objective is to estimate the per patient sensitivity of combined
CTCA/dynamic CTP for diagnosis of hemodynamically significant coronary artery
disease with ICA/FFR as reference standard.
Study design
This study is a single centre diagnostic-cross sectional study focussing on the
index test (CTCA and dynamic stress CTP) with reference standard (ICA with
FFR/iFR and OCT).
Study burden and risks
Additional CT examination (CTCA and CTP) with a mean/median estimated
additional radiation exposure of * 10 mSv will be performed during hospital
admission.
Geert Groteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Groteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Adult patient >18 years old
Patient presented with acute chest pain
Patient with positive troponins in blood
Patient diagnosed with a non-ST myocardial infarction by cardiologists
regardless of the GRACE score (based on the current ESC guidelines)
Patient who will undergo invasive coronary angiography within 72 hours after
admission (according to ESC guidelines).
Exclusion criteria
- Hemodynamically unstable patients, according to the treating cardiologist
- Patients after CABG
- Previous STEMI
- Previous episode of contrast allergy or anaphylaxis after intravenous
iodinated contrast administration
- Contra-indications for both adenosine and regadenoson administration
- Presence of pacemaker / ICD leads
- Renal insufficiency defined as Glomerular Filtration Rate (GFR) <30 ml/min
- Pregnancy
- Body Mass Index >35
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71531.091.19 |