Does angioplasty offer benefit over best medical treatment and supervised exercise training in mild to moderate intermittent claudication (MIMIC) patients?
| ISRCTN | ISRCTN37194085 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37194085 |
| Secondary identifying numbers | MREC 03/08/7 |
- Submission date
- 09/09/2005
- Registration date
- 11/11/2005
- Last edited
- 14/07/2010
- 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
Prof Roger Greenhalgh
Scientific
Scientific
Dept Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
| Phone | +44 (0)208 846 7316 |
|---|---|
| r.greenhalgh@imperial.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MIMIC |
| Study objectives | The aim of the MIMIC trials is to assess the adjuvant benefit of percutaneous transluminal angioplasty (PTA) in patients with Mild to Moderate Intermittent Claudication (MIMIC). All patients will receive best medical treatment, including advice to stop smoking and receive supervised exercise training for 6 months. 340 patients from 10 centres will be randomly allocated to receive angioplasty or not into one of two trials, one for aorto-iliac disease and another for femoro-popliteal disease and followed up for 2 years. It is expected that the MIMIC trials will show whether either aorto-iliac or femoro-popliteal angioplasty are of adjuvant benefit to best medical treatment and exercise therapy in terms of Absolute Walking Distance (AWD) as the primary endpoint, and secondly in terms of both specific and generic health related quality of life (HRQL) measures and, if beneficial, the cost effectiveness of the additional intervention. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Intermittent claudication; peripheral vascular disease |
| Intervention | Supervised exercise therapy versus supervised exercise therapy and PTA. |
| Intervention type | Other |
| Primary outcome measure | AWD at 2 years compared to baseline. |
| Secondary outcome measures | 1. Generic and disease specific quality of life questionnaires 2. Cost economics 3. Patency |
| Overall study start date | 01/02/2003 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 340 |
| Key inclusion criteria | 1. Patients with stable mild to moderate intermittent claudication 2. Patients satisfying the criteria of the Edinburgh Claudication Questionnaire 3. Patients suitable for aorto-iliac or femoro-popliteal PTA after duplex mapping or diagnostic arteriography 4. Ankle Brachial Pressure Indices (ABPI) <0.9 or >0.9 with a positive stress test i.e. a fall of >30 mmHg following a treadmill test at 4 km/h, 10 degree slope for 1 min |
| Key exclusion criteria | 1. Patients with intermittent claudication too mild for patient or doctor to consider PTA 2. Patients with intermittent claudication severe enough to merit consideration of bypass surgery 3. Patients with critical ischaemia i.e. absolute Doppler pressure <50 mmHg, or presence of ulcers or gangrene with a Doppler pressure >50 mmHg 4. Patients with ankle/brachial pressure index (ABPI) >0.9 with a negative stress test who could have sciatica or very mild peripheral arterial disease (insignificant arterial disease) 5. Patients with musculoskeletal, cardiac or any other concomitant disease that renders consideration for supervised exercise inappropriate |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept Vascular Surgery
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
Clinical Research Office
Imperial College London
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Industry
Camelia Botnar Arterial Research Foundation (UK)
No information available
Bard Ltd (UK)
No information available
Boston Scientific Ltd (UK)
No information available
Cook UK Ltd (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
