Individualized Physical Activity and Carotid Plaque Instability
PACAPh
Effect of an Individualized Home-based Physical Activity Trial on Carotid Plaque Vulnerability for Asymptomatic Patients
2 other identifiers
interventional
56
1 country
1
Brief Summary
Intraplaque hemorrhage (IPH) is one of the main features of the carotid plaque instability's and predictor of ischemic stroke. Benefits (on the basis on benefit/risk ratio) of the carotid endarterectomy remain unclear for stroke asymptomatic patients; thus, more and more patients with important stenosis (i.e. over 60%) detected are not operated. However, these patients need adapted therapeutic treatments to limit plaque instability and this should include physical activity (PA). Indeed, PA has been showed to decrease numerous inflammatory markers involved in atherosclerosis. It has also recently been reported on stroke asymptomatic patients that the prevalence of carotid IPH was decreased in those with higher level of PA. Magnetic Resonance Imaging (MRI) of the IPH has been shown to be the better non-invasive imaging technique to assess carotid plaque instability and in particular IPH. Here, the aim of this study is to assess the effect of an individualized home-based 6 months physical activity intervention on carotid IPH and other biomarkers of vulnerability for asymptomatic patients. This study has been designed as a monocentric, longitudinal and interventional study. This study will involve one centre: Hopital Louis Pradel (HCL, Lyon). After inclusion tests, patients will be randomly included in the control group, or in the PA group. Patients of the PA group will have connected bracelets to measure daily count of steps. Twice a month, daily goals will be revaluated to increase or maintain the steps per day. The final goal is to reach 6 000 steps per day or increase by 30% the initial count of steps per day. Same tests will be done after 6 months of intervention for comparison.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 12, 2019
CompletedStudy Start
First participant enrolled
December 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2022
CompletedDecember 19, 2025
December 1, 2025
2.8 years
August 6, 2019
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
decreased intensity of IPH levels measured by MRI
Image quality will be assessed from 1 to 5 (grade 1, low Signal-to-Noise Ratio (SNR) limits use, arterial wall and vessel margins are unidentifiable; grade 2, marginal SNR, arterial wall is visible, but the substructure, lumen, and outer boundaries are indistinct; grade 3, marginal SNR, wall structures are identifiable, but lumen and outer boundaries are partially obscured; grade 4, high SNR with minimal artifacts, vessel wall, lumen, and adventitial margins are well defined; and grade 5, high SNR without artifacts, wall architecture depicted in detail, lumen and adventitial boundary are clearly defined) . If the quality of the image is sufficient (≥ 3), IPH levels will be semi-quantified on a scale from 0 to 3 (0: No IPH, 1: light IPH, 2 moderate IPH, strong IPH). Images will be assessed blindly and independently by clinical experts of carotid plaque imaging.
Day 0
decreased intensity of IPH levels measured by MRI
Image quality will be assessed from 1 to 5 (grade 1, low Signal-to-Noise Ratio (SNR) limits use, arterial wall and vessel margins are unidentifiable; grade 2, marginal SNR, arterial wall is visible, but the substructure, lumen, and outer boundaries are indistinct; grade 3, marginal SNR, wall structures are identifiable, but lumen and outer boundaries are partially obscured; grade 4, high SNR with minimal artifacts, vessel wall, lumen, and adventitial margins are well defined; and grade 5, high SNR without artifacts, wall architecture depicted in detail, lumen and adventitial boundary are clearly defined) . If the quality of the image is sufficient (≥ 3), IPH levels will be semi-quantified on a scale from 0 to 3 (0: No IPH, 1: light IPH, 2 moderate IPH, strong IPH). Images will be assessed blindly and independently by clinical experts of carotid plaque imaging.
Month 6
Secondary Outcomes (42)
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Day 0
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Month 6
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Day 0
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Month 6
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
Day 0
- +37 more secondary outcomes
Study Arms (2)
Individualized home-based physical activity
EXPERIMENTALThe subjects of this arm will have a daily goal in number of steps based on the initial 2 first week evaluation of daily number of steps. They will wear connected wrists, and will be contacted twice a month by phone call by the adapted physical activity trainer to revaluate these goals.
Control group
ACTIVE COMPARATORThe subjects of this arm will not have evaluation of daily steps and recommendations regarding physical activity and sedentary behaviour. They will be asked to live as usual.
Interventions
Subjects will have to reach a daily goal in number of steps, based on the initial evaluation, during 6 months . They will wear connected wrists, and will be contacted twice a month by phone call by an adapted physical activity to revaluate these goals.
An MRI will be performed for each patient at the end of the study to identify IPH and other features of histological vulnerability (lipid core, fibrous cap integrity and calcifications).
Blood will be collected, to analyse monocyte phenotype by flow cytometry, blood rheology by ektacytometry, coagulation by rotational thromboelastometry (ROTEM). Plasma will be extracted from blood to assess inflammation, oxidative stress and antioxidant markers.
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
The 6-minute walk test is a simple, individualized test that measures how fast a patient walks on a flat, hard surface for 6 minutes.
Eligibility Criteria
You may qualify if:
- Patient with an carotid atheromatous plaque with ≥ 50% North American Symptomatic Carotid Endarterectomy Trial (NASCET) stenosis
- Patient from vascular surgery department of the Louis Pradel Hospital of the Hospices Civils de Lyon, but not operated
- Males and females aged over 18 years old
- No contra-indication to physical activity with index performance (PS) \< 2
- Available and voluntary to invest in the study throughout its duration (6 months)
- Able to understand, read and write French;
- a social security system or similar;
- Having dated and signed informed consent.
You may not qualify if:
- Transient ischemic attack (TIA) or ipsilateral cerebral infarction less than 6 months
- History of ipsilateral carotid surgery or cervical irradiation;
- Cancer, heart failure, seropositivity;
- Coronary risk;
- Renal failure (Cockcroft clearance of creatinine \< 30 milliliter/minute (mL/min);
- Contraindication and precautions for use related to Prohance: hypersensitivity to the active substance or to any of the constituents of Prohance, renal insufficiency with clearance \<30 ml / min / 1.73 m², probability of convulsions during the higher examination in patients with epilepsy or brain injury, pregnancy, breastfeeding;
- Contraindication to MRI: ferromagnetic material (including pacemaker, implantable defibrillators, cardiac valve prostheses, cochlear implants, neurostimulators, implanted automated injection equipment, intraocular metallic foreign bodies, neurosurgical and vascular clips);
- Carotid occlusion;
- ipsilateral intracranial stenosis;
- Risk of pregnancy or proven pregnancy on interrogation data. Breastfeeding;
- Patient under guardianship, under curatorship or safeguard of justice;
- inability to express consent;
- uncontrolled cardiological or neurological diseases;
- Impossibility of being followed for medical, social, geographical or psychological reasons throughout the duration of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Louis Pradel
Bron, 69500, France
Related Publications (2)
Mura M, Rivoire E, Dehina-Khenniche L, Weiss-Gayet M, Chazaud B, Faes C, Connes P, Long A, Rytz CL, Mury P, Delrieu L, Gouraud E, Bordet M, Della Schiava N, Lermusiaux P, Arsicot M, Millon A, Pialoux V. Effectiveness of an individualized home-based physical activity program in surgery-free non-endarterectomized asymptomatic stroke patients: a study protocol for the PACAPh interventional randomized trial. Trials. 2022 Feb 14;23(1):145. doi: 10.1186/s13063-022-06061-x.
PMID: 35164816RESULTMura M, Rivoire E, Dehina-Khenniche L, Jazzar G, Schlatter S, Della-Schiava N, Arsicot M, Fayad ZA, Lermusiaux P, Long A, Douek P, Chirico EN, Thomas A, Pialoux V, Millon A. Influence of a six-month home-based individualized physical activity intervention on carotid plaque instability measured by magnetic resonance imaging: a randomized controlled clinical trial. EClinicalMedicine. 2025 Apr 22;83:103158. doi: 10.1016/j.eclinm.2025.103158. eCollection 2025 May.
PMID: 40548131RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Two experienced observers will blindly read the MRI scans.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 12, 2019
Study Start
December 3, 2019
Primary Completion
September 12, 2022
Study Completion
September 21, 2022
Last Updated
December 19, 2025
Record last verified: 2025-12