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Iodinated contrast dilution in imaging lower limbs of patients with peripheral arterial disease.


- candidate number12287
- NTR NumberNTR3406
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2012
- Secondary IDs2011_268 METC AMC
- Public TitleIodinated contrast dilution in imaging lower limbs of patients with peripheral arterial disease.
- Scientific TitleIOdinated contrast DILution in digital subtraction angiography of the limb: A randomized controlled noninferiority trial with three different concentrations of iodine.
- ACRONYMIODIL
- hypothesisDigital subtraction angiography can be performed at a lower iodinated contrast concentration than currently used, without loss of anatomical information and image quality.
- Healt Condition(s) or Problem(s) studiedIntermittent claudication, Critical limb ischemia, Peripheral arterial disease (PAD)
- Inclusion criteriaPAD, 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 criteria1. Renal failure; serum creatinine > 130 Ámol/l;
2. Inability to give informed consent, or;
3. Patient participation in another study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 16-apr-2012
- planned closingdate16-apr-2013
- Target number of participants60
- InterventionsDigital subtraction angiography will be performed using the assigned iodinated contrast concentration (i.e. Omnipaque 300, 240 or 140 mg iodine/ml).
- Primary outcomeConfidence in diagnosing and treating arterial stenoses or occlusions.
- Secondary outcomeImage quality scores.
- TimepointsThe patient gets the intervention with the assigned contrast and 2-3 days after the procedure, blood will be withdrawn to assess renal function.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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. S. Jens
- CONTACT for SCIENTIFIC QUERIESDrs. S. Jens
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
GE Healthcare
- PublicationsN/A
- Brief summaryPeripheral 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.
- Main changes (audit trail)
- RECORD24-apr-2012 - 9-mei-2012


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