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

IOdinated contrast DILution in digital subtraction angiography of the limb: A randomized controlled noninferiority trial with three different concentrations of iodine.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21387

Enrollment

Registered

2012-04-24

Start date

2012-04-16

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease Critical Limb Ischemia Intermittent Claudication

Interventions

Digital subtraction angiography will be performed using the assigned iodinated contrast concentration (i.e. Omnipaque 300, 240 or 140 mg iodine/ml).

Eligibility

Inclusion criteria

Inclusion criteria: PAD, either IC or CLI, as defined by surgeon based on patient history, with: 1. Ankle-brachial pressure index (ABPI) 0.15 after exercise, or; 3. Toe-brachial pressure index (TBPI) 2 weeks; 5. Scheduled for DSA with antegrade femoral puncture; 6. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Renal failure; serum creatinine > 130 µmol/l; 2. Inability to give informed consent, or; 3. Patient participation in another study.

Design outcomes

Primary

Measure	Time frame
Confidence in diagnosing and treating arterial stenoses or occlusions.	—

Secondary

Measure	Time frame
Image quality scores.	—

Contacts

Public ContactS. Jens

Room G1-229 Academic Medical Center Meibergdreef 9

s.jens@amc.uva.nl+31 (0)20 5666495

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)