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

Dept Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Phone +44 (0)208 846 7316
Email r.greenhalgh@imperial.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymMIMIC
Study objectivesThe 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) studiedIntermittent claudication; peripheral vascular disease
InterventionSupervised exercise therapy versus supervised exercise therapy and PTA.
Intervention typeOther
Primary outcome measureAWD at 2 years compared to baseline.
Secondary outcome measures1. Generic and disease specific quality of life questionnaires
2. Cost economics
3. Patency
Overall study start date01/02/2003
Completion date31/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants340
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2003
Date of final enrolment31/01/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Dept Vascular Surgery
London
W6 8RF
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

Clinical Research Office
Imperial College London
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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