Last updated: August 2, 2021
Sponsor: Centre Hospitalier Universitaire Vaudois
Overall Status: Active - Recruiting
Phase
N/A
Condition
Surgery
Treatment
N/AClinical Study ID
NCT04627688
2019-02483
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years
- Fontaine stage II peripheral artery disease planned for open femoral endarterectomy
- Body mass index ≥ 20 kg/m2
- Smartphone compatible with the app (iOS or Android systems)
- Hypertensive (or on 1 or more blood pressure lowering medication)
- Hypercholesterolemia (or on 1 or more lipid lowering medication)
Exclusion
Exclusion Criteria:
- Diabetes on insulin therapy or sulfonylureas
- Fontaine stage III and IV peripheral artery disease
- Prior revascularization on the index leg within 14 days of the qualifyingrevascularization.
- Major surgery in the past 3 months
- Myocardial infarction or revascularization (PTA, stent, CABG) in the past 3 months
- Major illness / fever over the previous month, active cancer
- On a diet / weight management or prior bariatric surgery
- Major mental illness, unable to give consent, inability to follow study procedures (language barrier, dementia)
- Current shift work or travel abroad planned in the next month
- Major sleep disorder
- Enrolled in another interventional clinical trial
- Ongoing pregnancy
Study Design
Total Participants: 40
Study Start date:
January 25, 2021
Estimated Completion Date:
July 01, 2023
Connect with a study center
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Vaud 1011
SwitzerlandActive - Recruiting
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
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