Contact information
Type
Scientific
Primary contact
Prof Roger Greenhalgh
ORCID ID
Contact details
Dept Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)208 846 7316
r.greenhalgh@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MREC 03/08/7
Study information
Scientific title
Acronym
MIMIC
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Intermittent claudication; peripheral vascular disease
Intervention
Supervised exercise therapy versus supervised exercise therapy and PTA.
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
01/02/2003
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
340
Participant 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
Recruitment start date
01/02/2003
Recruitment end date
31/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept Vascular Surgery
London
W6 8RF
United Kingdom
Funders
Funder type
Industry
Funder name
Camelia Botnar Arterial Research Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bard Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Boston Scientific Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cook UK Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19022184
Publication citations
-
Results
Greenhalgh RM, Belch JJ, Brown LC, Gaines PA, Gao L, Reise JA, Thompson SG, , The adjuvant benefit of angioplasty in patients with mild to moderate intermittent claudication (MIMIC) managed by supervised exercise, smoking cessation advice and best medical therapy: results from two randomised trials for stenotic femoropopliteal and aortoiliac arterial disease., Eur J Vasc Endovasc Surg, 2008, 36, 6, 680-688, doi: 10.1016/j.ejvs.2008.10.007.