Abstract
BackgroundCarotid atherosclerotic plaques remain silent until their rupture, which may lead to detrimental ischemic events such as strokes. This is due, in part, to intraplaque hemorrhages (IPH) and the resulting inflammatory processes, which may promote carotid plaque vulnerability. Currently, the benefits of carotid endarterectomy remain unclear for asymptomatic patients. Interestingly, the completion of physical activity (PA) may have beneficial effects; however, the paucity of current data warrants robust longitudinal interventions. We therefore aim to study the effects of a 6-month longitudinal personalized home-based PA program on IPH, biological, and inflammatory markers in asymptomatic stroke patients.MethodsEighty patients (≥ 18 years old) will be recruited for the Physical Activity and Carotid Atherosclerotic Plaque Hemorrhage (PACAPh) clinical trial from the Hospices Civils de Lyon. Patients will be eligible if they present with carotid stenosis ≥ 50% and are asymptomatic from any ischemic events for at least 6 months. Recruited patients will be randomized into either a PA or a control group, and assessed at baseline and after 6 months. At both time points, all patients will be assessed using magnetic resonance imaging to assess IPH, blood sampling to measure inflammatory markers and monocytic phenotyping, PA and sedentary behavior questionnaires, 6-min walking test, and maximal isometric quadricep contraction test. The randomized PA intervention will consist of reaching a daily walking step goal individually tailored to each patient. Steps will be collected using a wirelessly connected wristband. The number of steps completed by individuals in the PA group will be re-evaluated bimonthly to encourage walking habits.DiscussionThe PACAPh study is the first of its kind representing a feasible, easily accessible therapeutic strategy for asymptomatic stroke patients. We hypothesize that the personalized home-based PA program will reduce IPH and modulate inflammatory and biological parameters in patients presenting with carotid plaques. If the results of the PACAPh study prove to be beneficial on such health parameters, the implementation of such kind of intervention in the daily treatment of these patients would be an advantageous and cost-effective practice to adopt globally.Trial registrationThis study has been approved by the National Ethics Committee (IDRCB:2019-A01543-54/SI:19.06.21.40640). ClinicalTrials.gov NCT04053166
Highlights
Carotid atherosclerotic plaques remain silent until their rupture, which may lead to detrimental ischemic events such as strokes
We hypothesize that the personalized home-based physical activity (PA) program will reduce intraplaque hemorrhages (IPH) and modulate inflammatory and biological parameters in patients presenting with carotid plaques
European guidelines suggest that patients who do not present with clinical symptoms or plaque vulnerability factors should not undergo carotid endarterectomy (CEA) [5]
Summary
Study design The PACAPh study is a longitudinal, interventional, monocentric, randomized controlled study sponsored by the Hospices Civils de Lyon (Lyon, France) (Fig. 1). Control group Patients randomized into the control group will only wear the activity tracker for 14 days following visit #1 and 14 days before visit #2 in order to measure daily walking habits and step counts. For both study visits (#1 and #2), the PA instructor will perform the physical assessments, and blood samples will be taken by a registered nurse. Juxtaluminal hemorrhages will be deemed as IPH, and the fibrous cap status will be recorded regardless of the presence or absence of IPH Both experts will visually analyze signal changes in the vessel walls in the post-contrast images and will compare them to corresponding pre-contrast images and will complete contouring of the region of interest where uptake is found.
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