TY - JOUR
T1 - Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication
T2 - the ELECT Registry
AU - van den Houten, Marijn M. L.
AU - Jansen, Sandra C. P.
AU - Sinnige, Anneroos
AU - van der Laan, Lijckle
AU - Vriens, Patrick W. H. E.
AU - Willigendael, Edith M.
AU - Lardenoije, Jan-Willem H. P.
AU - Elshof, Jan-Willem M.
AU - van Hattum, Eline S.
AU - Lijkwan, Maarten A.
AU - Nyklicek, Ivan
AU - Rouwet, Ellen V.
AU - Koelemay, Mark J. W.
AU - Scheltinga, Marc R. M.
AU - Teijink, Joep A. W.
N1 - Funding Information:
This trial does not hamper routine vascular surgery or physical therapy treatment for the participants. Furthermore, it mainly records diagnostic and outcome measures that are performed as part of the usual clinical routine, supplemented by several short, non-intrusive questionnaires. Therefore, the ELECT Registry has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United ‘MEC-U’ (reference number W17.071). Nonetheless, privacy laws require that each subject must authorise the treating physician(s), therapists and institutions to release their medical information. Each subject must therefore sign a patient informed consent form before any data can be sent to the coordinating centre. The results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally.
Publisher Copyright:
© 2019 Author(s).
PY - 2019/6
Y1 - 2019/6
N2 - Introduction Despite 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 analysis This 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 dissemination This 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.
AB - Introduction Despite 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 analysis This 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 dissemination This 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.
KW - QUALITY-OF-LIFE
KW - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY
KW - ENDOVASCULAR REVASCULARIZATION
KW - CLINICAL EFFECTIVENESS
KW - DUTCH TRANSLATION
KW - HOSPITAL ANXIETY
KW - THERAPY
KW - FEMOROPOPLITEAL
KW - TRIAL
KW - CLASSIFICATION
U2 - 10.1136/bmjopen-2018-025419
DO - 10.1136/bmjopen-2018-025419
M3 - Article
C2 - 30782932
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - 025419
ER -