Digital subtraction angiography can be performed at a lower iodinated contrast concentration than currently used, without loss of anatomical information and image quality.
ID
Bron
Verkorte titel
Aandoening
Peripheral Arterial Disease
Critical Limb Ischemia
Intermittent Claudication
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Confidence in diagnosing and treating arterial stenoses or occlusions.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Digital subtraction angiography can be performed at a lower iodinated contrast concentration than currently used, without loss of anatomical information and image quality.
Onderzoeksopzet
The patient gets the intervention with the assigned contrast and 2-3 days after the procedure, blood will be withdrawn to assess renal function.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.
Onderzoeksproduct en/of interventie
Digital subtraction angiography will be performed using the assigned iodinated contrast concentration (i.e. Omnipaque 300, 240 or 140 mg iodine/ml).
Publiek
Academic Medical Center<br>
Meibergdreef 9
S. Jens
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666495
s.jens@amc.uva.nl
Wetenschappelijk
Academic Medical Center<br>
Meibergdreef 9
S. Jens
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666495
s.jens@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Renal failure; serum creatinine > 130 µmol/l;
2. Inability to give informed consent, or;
3. Patient participation in another study.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3254 |
| NTR-old | NTR3406 |
| Ander register | METC AMC : 2011_268 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |