Diagnostic Imaging for Peripheral Arterial Disease: the DIPAD trial

ISRCTN	ISRCTN26717851
DOI	https://doi.org/10.1186/ISRCTN26717851

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr R. Ouwendijk
Scientific

Department of Radiology
Erasmus Medical Center Rotterdam
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Email	r.ouwendijk@erasmusmc.nl

Study design	Multicentre, randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	Diagnostic Imaging for Peripheral Arterial Disease: the DIPAD trial
Study acronym	DIPAD trial
Study hypothesis	Is the diagnostic imaging workup of patients with peripheral arterial disease performed initially with Magnetic Resonance (MR) angiography cost-effective compared to the currently employed workup with duplex ultrasound or Computed Tomography (CT) angiography?
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Condition	Peripheral Arterial Disease (PAD)
Intervention	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
Intervention type	Other
Primary outcome measure	Primary outcomes evaluated were quality of life and costs.
Secondary outcome measures	Secondary outcomes evaluated were clinical utility and functional patient outcomes.
Overall study start date	01/12/2001
Overall study end date	01/10/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	514
Participant inclusion criteria	1. Men and women at least 18 years old 2. Symptomatic Peripheral Arterial Disease (PAD) 3. An ankle-brachial index less than 0.90 4. Referred from the Department of Vascular Surgery for a diagnostic imaging workup to evaluate the feasibility of a revascularisation procedure
Participant exclusion criteria	1. Contraindications for MR angiography (e.g., pacemaker, cerebral vessel clipping, or claustrophobia) or CT angiography (e.g., severe renal insufficiency or adverse reactions to iodinated contrast agent) 2. Need an acute intervention at time of randomisation
Recruitment start date	01/12/2001
Recruitment end date	01/10/2003

Department of Radiology

Rotterdam
3000 CA
Netherlands

Erasmus Medical Centre (Netherlands)
University/education

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Website	http://www.erasmusmc.nl/
"ROR"	https://ror.org/018906e22

Research organisation

The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/09/2005		Yes	No
Results article		01/08/2006		Yes	No

09/11/2022: Internal review.