Diagnostic Imaging for Peripheral Arterial Disease: the DIPAD trial
| ISRCTN | ISRCTN26717851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26717851 |
| Protocol serial number | Nil known |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funder | The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 09/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R. Ouwendijk
Scientific
Scientific
Department of Radiology
Erasmus Medical Center Rotterdam
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| r.ouwendijk@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Diagnostic Imaging for Peripheral Arterial Disease: the DIPAD trial |
| Study acronym | DIPAD trial |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Primary outcomes evaluated were quality of life and costs. |
| Key secondary outcome measure(s) |
Secondary outcomes evaluated were clinical utility and functional patient outcomes. |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 514 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Radiology
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| 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 |
Editorial Notes
09/11/2022: Internal review.
