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Diagnostic Imaging for Peripheral Arterial Disease: the DIPAD trial.

Completed
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 < 0.90.
Registration Number
NL-OMON26004
Lead Sponsor
-Prof. Dr. M.G.M. HuninkDept 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 EngelshovenDept of RadiologyAcademic Hospital MaastrichtP.O. box 58006202 AZ Maastricht
Brief Summary

1. AJR Am J Roentgenol. 2008 May;190(5):1349-57; <br> 2. Radiology. 2005 Sep;236(3):1094-1103;<br> 3. J Vasc Surg. 2005 Feb;41(2):261-268.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
514
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcomes evaluated were quality of life and costs.
Secondary Outcome Measures
NameTimeMethod
Secondary outcomes evaluated were clinical utility and functional patient outcomes.
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