The objective of this cross-sectional study is to assess the relation between plaque characteristics, detected by Coronary Computed Tomography Angiography (CCTA) and Intravascular Optical Coherence Tomography (IVOCT), and the hemodynamic…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
On the CCTA images the presence of calcified, mixed and non-calcified plaques
will be assessed. FFR and CFR will be measured in all vessels with 40-70%
stenosis. FFR < 0.80 and CFR < 2.0 will be considered hemodynamically
significant.
To assess the presence of TCFA all patients will undergo an additional IVOCT of
approximately 15 minutes during the heart catheterisation. IVOCT-TCFA will be
defined as an IVOCT-delineated necrotic core with an overlying fibrous cap
where the thickness of the fibrous cap is less than 65 µm.
Secondary outcome
nvt
Background summary
Important features associated with the occurrence of an acute myocardial
infarction are the presence of a thin capped fibroatheroma (TCFA),
non-calcified plaques and hemodynamic significant stenoses. The association
between these features remains unclear.
Study objective
The objective of this cross-sectional study is to assess the relation between
plaque characteristics, detected by Coronary Computed Tomography Angiography
(CCTA) and Intravascular Optical Coherence Tomography (IVOCT), and the
hemodynamic consequences of coronary lesions.
Study design
Cross-sectional diagnostic study.
Study burden and risks
The patients included in this study are patients also partcipating in study
11-464. In study 11-464 patients will undergo a CT-scan of the coronary
arteries. These results will be used in this study.
For this study the patients will undergo an IVOCT. There are only transient
electrocardiographic changes reported in literature. No serious complication
are described. This study will extent the duration of the heart catheterisation
with 15 minutes.
Plaque composition and the hemodynamic consequence of a coronary lesion are two
important predictors of a heart infarction. The relation between these
predictors is unclear. This study will contribute to this knowlegde and might
change cardiovascular risk prediction and treatment in future patients.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- patients scheduled for coronary angiography (CAG)in combination with fractional flow reserve (FFR)/ coronary flow reserve (CFR) measurements
- 18 years or older
- signed, written informed consent
- informed consent for study 11-464
Exclusion criteria
- acute coronary syndrome
- atrial fibrillation
- previous coronary bypass graft surgery
- previous myocardial infarction
- impaired left ventricular (LV) function (ejection fraction < 40%),
- obstructive pulmonary disease
- pregnancy or possible pregnancy
- lactation
- documented allergic reaction to gadolinium or iopromide
The same as is study 11-464:
- subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2)
- impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes)
Design
Recruitment
Medical products/devices used
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 | NL41946.041.12 |