Condition category
Circulatory System
Date applied
09/09/2005
Date assigned
11/11/2005
Last edited
14/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19022184

Publication citations

  1. 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.

Additional files

Editorial Notes