The main objective of this study is to assess perfusion of the foot and correlate perfusion values with arterial patency. To this end, first the PCT protocol of the foot in patients with CLI needs to be optimized in terms of contrast dose…
ID
Source
Brief title
Condition
- Skin vascular abnormalities
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Signal/contrast to noise ratio of the PCT scans
- PCT imaging quality scores
- PCT perfusion values (blood volume, blood flow, time to peak and mean transit
time) of different predefined regions of the ischemic and non-ischemic foot
- Pedal arterial patency based on DSA
Secondary outcome
No secundary study parameters/outcomes
Background summary
Critical limb ischemia (CLI) is a severe symptom of peripheral arterial disease
(PAD) and is characterized by ischemic pain at rest or non-healing ischemic
ulcers or gangrene in the lower extremity. Revascularization of the limb is
currently the only intervention which can achieve limb salvage. However,
selecting patients who will benefit from revascularization based on current
imaging modalities remains challenging. Therefore, imaging techniques to assess
the microvascular status of the lower limb are needed. Perfusion CT may be a
good technique to assess the microvascular status, as this modality has already
showed its usefulness in the field of neurology in patients with ischemic
stroke.
Study objective
The main objective of this study is to assess perfusion of the foot and
correlate perfusion values with arterial patency. To this end, first the PCT
protocol of the foot in patients with CLI needs to be optimized in terms of
contrast dose administration (volume, concentration and rate of administration)
and imaging quality.
Study design
This will be a bipartite prospective study including 18 patients in total. The
first 8 patients will be studied to optimize the contrast injection protocol of
PCT, the next ten patients will be evaluated to assess perfusion values and
correlate these to digital subtraction angiography (DSA).
Study burden and risks
There are no benefits for the patients participating in this study. Patients
undergo a CT procedure with administration of iodinated contrast. Next to the
risk of the radiation from the CT, the contrast material brings a risk for
contrast-induced nephropathy or allergic reaction. The health risk from this
radiation in this population is graded as a *minor risk*, since the effective
dose will be around 0.4 mSv per patient. The risk for contrast-induced
nephropathy is mainly applicable to patients with chronic renal failure, who
are excluded from this study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- rest pain, nonhealing ulceration or gangrene of the foot, i.e. Fontaine III/IV
- ankle-brachial pressure index (ABPI) < 0.7 or toe pressure < 50 mmHg
- critical limb ischemia > 2 weeks
- normal renal function (i.e. creatinine <130*mol/l)
- written informed consent
Exclusion criteria
- inability to give informed consent
- contraindications for contrast-enhanced CT, i.e. allergic reactions to iodinated contrast agents or pregnancy
- major amputation; amputation above the level of the ankle
- patient participates in another study
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 | NL42541.018.12 |