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Diagnostic Imaging for Peripheral Arterial Disease: the DIPAD trial.

Diagnostic Imaging of Peripheral Arterial Disease (DIPAD) randomized trial to compare outcomes following duplex ultrasound, computed tomographic angiography, and magnetic resonance angiography as the initial imaging test in the diagnostic workup of patients with peripheral arterial disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26004
Enrollment
514
Registered
2005-09-08
Start date
2001-12-01
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 (PAD) is the expression of atherosclerosis in the lower limb distal to the aortic bifurcation, which is a major problem in the population of 55 years and older. The first manifestation of symptomatic PAD is usually intermittent claudication. In a minority of patients, the disease progresses to critical limb ischemia, i.e. rest pain and tissue necrosis. PAD was defined as symptoms of intermittent claudication and/ or critical ischemia with an ankle-brachial index < 0.

Interventions

1. Magnetic resonance angiography: requires intravenous contrast material injection and duration of the examination is 30 minutes
2. Duplex ultrasound: requires no intravenous contrast material injection and duration of the examination is variable
3. Computed tomographic angiography:requires intravenous contrast material injection and duration of the examination is 10 minutes.

Sponsors

-Prof. Dr. M.G.M. Hunink Dept of Radiology and Dept of Epidemiology & Biostatistics, Program for the Assessment of Radiological Technology (ART), Erasmus Medical Center Rotterdam -Prof. Dr. J.M.A. van Engelshoven Dept of Radiology Academic Hospital Maastricht P.O. box 5800 6202 AZ Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men and women at least 18 years old with symptomatic PAD and an ankle-brachial index <0.90 who were referred from the Department of Vascular Surgery for a diagnostic imaging workup to evaluate the feasibility of a revascularization procedure were eligible for enrollment.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had contraindications for MR angiography (eg, pacemaker, cerebral vessel clipping, or claustrophobia) or CT angiography (eg, severe renal insuffiency or adverse reactions to iodinated contrast agent), or if they needed an acute intervention at the time of randomization.

Design outcomes

Primary

MeasureTime frame
Primary outcomes evaluated were quality of life and costs.

Secondary

MeasureTime frame
Secondary outcomes evaluated were clinical utility and functional patient outcomes.

Contacts

Public ContactR. Ouwendijk

Erasmus Medical Center, Department of Radiology, P.O. Box 2040

r.ouwendijk@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)