To assess the degree of arterial wall inflammation as measured by 18F-FDG-PET/CT in subjects with chronic kidney disease.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the 18F-FDG -PET/CT measurements of arterial wall
inflammation (target-to-background ratio) compared to healthy control subjects.
Secondary outcome
To assess the correlation between the degree of arterial wall inflammation as
assessed with 18F-FDG -PET/CT and circulating markers of inflammation and renal
failure.
Background summary
Reduced eGFR is associated with an increased risk of cardiovascular mortality,
independent of traditional risk factors. As chronic kidney disease (CKD)
affects approximately 8% of the population, this association causes a major
public health burden. Over the last decades, the role of inflammation in the
pathophysiology of atherosclerosis has become increasingly important, and CKD
has been associated with an increased inflammatory state.
18F-FDG-PET/CT is a nuclear imaging technique which measures metabolic activity
by labelling glucose with a PET tracer (18-fluor), and is used as a read-out
for atherosclerotic plaque inflammation. This technique has been safely applied
in subjects with CKD.
Study objective
To assess the degree of arterial wall inflammation as measured by
18F-FDG-PET/CT in subjects with chronic kidney disease.
Study design
This study is designed as a single center, observational study. After screening
for eligibility, all subjects will undergo cardiovascular risk assessment and
laboratory testing. Thereafter, all subjects will undergo an 18F-FDG -PET/CT
scan.
Study burden and risks
The results of this study contribute to our understanding of accelerated
atherosclerosis in subjects with chronic renal disease, thereby contributing to
risk stratification in individual patients and development of new
anti-atherosclerotic treatment. Individual subjects will gain no direct benefit
from this study.
The risk and burden of participating in this study is estimated to be low.
Patients will visit the hospital on one occasion for a maximum of 2 hours, the
exposure to radiation related to 18F-FDG PET/CT scan is 5.3 mSv in this study.
18F-FDG PET/CT have been safely applied in subjects with decreased renal
function.
Meibergdreef 9
Amsterdam Zuid Oost 1105 AZ
NL
Meibergdreef 9
Amsterdam Zuid Oost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Aged 50 years or older
2. Chronic Kidney Disease stages 3 and 4 (eGFR: 15-60 ml min-1)
Exclusion criteria
1. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
2. Standard contra-indications to 18F-FDG PET, and CT based on physicians experience and current practices: Claustrophobia, Metal in the body, as a result of e.g. osteosynthetic material, pacemaker implantation or artificial cardiac valves.
3. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
4. Participation in a scientific study with radiation exposure in the year prior to inclusion.
5. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons.
6. Planned or expected diagnostic procedures with radiation exposure due to a medical condition
7. Clinical signs of acute infection and/or CRP>10
8. History of MI/Stroke or known coronary artery disease
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 | NL48486.018.14 |