To explore FDG-PET/CT to quantify the effect of CABG on inflammation in the arterial wall.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage change in FDG uptake after CABG as compared with baseline in the
arterial wall of aortic arch, carotid arteries and descending aorta.
Secondary outcome
Not applicable
Background summary
Patients who undergo Coronary Artery Bypass Grafting (CABG) supported by
extracorporal circulation have 2-3 times more risk to experience an ischemic
Cerebro Vascular Accident (CVA) during the first year after surgery as compared
to similar patients who undergo a percutaeneous coronary angioplasty (PCA) for
revascularisation. We hypothesize that this increased risk is caused by an
arterial inflammatory response in aorta and carotid arteries triggered by this
major surgery and that this response can be visualized by FDG-PET/CT
(Fluor-deoxyglucose-positron emission tomography combined with computer
tomography). If true, this would provide us with an important tool to perform
phase 2 studies to select appropriate therapy to reduce the risk for CVA after
CABG.
Study objective
To explore FDG-PET/CT to quantify the effect of CABG on inflammation in the
arterial wall.
Study design
Observational pilot study that explores the effect of CABG on
deoxyglucose-uptake in the arterial wall of aortic arch, carotid arteries and
descending aorta as detected by FDG-PET/CT. A diagnostic procedure (FDG-PET/CT)
before CABG (at most 1 months interval) and during the first week after CABG
will be performed.
Study burden and risks
On top of the already scheduled CABG procedure, patients will undergo a
FDG-PET/CT twice. This diagnostic procedure will be performed according to
standard state-of-the-art clinical procedures at the department of Nuclear
Medicine. Duration of each procedure: 2 hours. Procedure-related exposure to
radioactivity: 13 mSv for two procedures (with a low-dose CT from skull base to
thigh). The main risk is the detection of still undiagnosed malignancy by
FDG-PET/CT. In such an event, the CABG surgery will not be cancelled or
delayed, but the patient will be offered an off-pump procedure. Any necessary
additional diagnostic procedures to optimally diagnose and treat the malignancy
will be performed after surgery, unless it is decided otherwise in the best
benefit of the patient).
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
* Age: at least 18 years
* Scheduled for CABG with extracorporal circulation
* Informed consent
Exclusion criteria
* MDRD-eGFR < 40 ml/min/1.73 m2
* History of polymyalgia rheumatica and/or giant cell arteritis
* Chronic use of anti-inflammatory drugs (such as NSAID's (acetylsalicylic acid <100 mg excluded) or prednison)
* History of a mycotic aneurysm.
* Any physical (for example movement disorders or severe orthopneu) or psychiatric condition (for example claustrophobia) that interferes with the ability for the patient to undergo a FDG-PET/CT scan.
* Active infection that interferes with imaging of aorta by FDG-PET/CT.
* Diabetes Mellitus
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 | NL49409.091.14 |