Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry

Author:

van den Houten Marijn MLORCID,Jansen Sandra CP,Sinnige Anneroos,van der Laan Lijckle,Vriens Patrick WHE,Willigendael Edith M,Lardenoije Jan-Willem HP,Elshof Jan-Willem M,van Hattum Eline S,Lijkwan Maarten A,Nyklíček Ivan,Rouwet Ellen V,Koelemay Mark JW,Scheltinga Marc RM,Teijink Joep AW

Abstract

IntroductionDespite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease.Methods and analysisThis multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1–3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient and vascular surgeon). For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CT angiography or magnetic resonance angiography). Changes in walking performance (treadmill tests, 6 min walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, WHO QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Freedom from revascularisation and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared using Kaplan-Meier survival curves.Ethics and disseminationThis study has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United ‘MEC-U’ (W17.071). Results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally.Trial registration numberNTR7332; Pre-results.

Publisher

BMJ

Subject

General Medicine

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