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 |
| Protocol serial number | MREC 03/08/7 |
| Sponsor | Imperial College London (UK) |
| Funders | Camelia Botnar Arterial Research Foundation (UK), Bard Ltd (UK), Boston Scientific Ltd (UK), Cook UK Ltd (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
AWD at 2 years compared to baseline. |
| Key secondary outcome measure(s) |
1. Generic and disease specific quality of life questionnaires |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Dept Vascular Surgery
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
