No registrations found.
ID
Source
Brief title
Health condition
Peripheral Arterial Disease
Critical Limb Ischemia
Intermittent Claudication
Sponsors and support
Intervention
Outcome measures
Primary outcome
Confidence in diagnosing and treating arterial stenoses or occlusions.
Secondary outcome
Image quality scores.
Background summary
Peripheral artery disease (PAD) is a disease which encompasses patients with intermittent claudication (IC) and critical limb ischemia (CLI). Many patients with PAD are treated for peripheral artery disease with endovascular intervention. For these interventions iodinated contrast media are used. The use of these media, leads in less than ten percent of patients with normal renal function to contrast induced nephropathy (CIN), an unexplained increase in serum creatinine of more than 25% or 44 mmol/l within three days of contrast administration, and increases to 25% in patients with pre-existent impaired renal function. To reduce this risk for CIN, minimizing volume and concentration of iodinated contrast administered during digital subtraction angiography (DSA) is advocated. To our knowledge, no study has been done considering the relation between iodinated contrast concentration and volume, and the qualitative aspects of DSA in patients with PAD. Therefore, we will study the influence of contrast dilution on the confidence of the interventional radiologist in performing DSA, image quality of DSA and renal function.
Study objective
Digital subtraction angiography can be performed at a lower iodinated contrast concentration than currently used, without loss of anatomical information and image quality.
Study design
The patient gets the intervention with the assigned contrast and 2-3 days after the procedure, blood will be withdrawn to assess renal function.
Three radiologists will score the standardized images on confidence in diagnosing and treating arterial stenoses and occlusions using a visual analogue scale. For the secondary outcome measures, the radiologists will also score image quality on a 4-point Likert Scale and eGFR will be calculated from the blood that has been drawed 2-3 days after the intervention.
Intervention
Digital subtraction angiography will be performed using the assigned iodinated contrast concentration (i.e. Omnipaque 300, 240 or 140 mg iodine/ml).
Academic Medical Center<br>
Meibergdreef 9
S. Jens
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666495
s.jens@amc.uva.nl
Academic Medical Center<br>
Meibergdreef 9
S. Jens
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666495
s.jens@amc.uva.nl
Inclusion criteria
PAD, either IC or CLI, as defined by surgeon based on patient history, with:
1. Ankle-brachial pressure index (ABPI) <0.90, or;
2. Drop in ABPI >0.15 after exercise, or;
3. Toe-brachial pressure index (TBPI) <0.70, and;
4. Duration of complaints > 2 weeks;
5. Scheduled for DSA with antegrade femoral puncture;
6. Informed consent.
Exclusion criteria
1. Renal failure; serum creatinine > 130 µmol/l;
2. Inability to give informed consent, or;
3. Patient participation 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 |
|---|---|
| NTR-new | NL3254 |
| NTR-old | NTR3406 |
| Other | METC AMC : 2011_268 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |