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ISRCTN
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ISRCTN37194085
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ClinicalTrials.gov identifier
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Public title
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Does angioplasty offer benefit over best medical treatment and supervised exercise training in mild to moderate intermittent claudication (MIMIC) patients?
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Scientific title
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Acronym
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MIMIC
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Serial number at source
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MREC 03/08/7
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Intermittent claudication; peripheral vascular disease
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/02/2003
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Anticipated end date
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31/01/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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340
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Interventions
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Supervised exercise therapy versus supervised exercise therapy and PTA.
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Primary outcome measure(s)
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AWD at 2 years compared to baseline.
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Secondary outcome measure(s)
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1. Generic and disease specific quality of life questionnaires
2. Cost economics
3. Patency
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Sources of funding
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1. Camelia Botnar Arterial Research Foundation (UK)
2. Bard Ltd (UK)
3. Boston Scientific Ltd (UK)
4. Cook UK Ltd (UK)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19022184
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Contact name
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Prof
Roger
Greenhalgh
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Address
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Dept Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Tel
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+44 (0)208 846 7316
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Fax
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+44 (0)208 846 7330
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Email
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r.greenhalgh@imperial.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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Clinical Research Office
Imperial College London
G02 Sir Alexander Fleming Building
South Kensington Campus
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Date applied
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09/09/2005
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Last edited
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14/07/2010
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Date ISRCTN assigned
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11/11/2005
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