Carotid AtherosclerosisPACAPhNCT04053166
Individualized Physical Activity and Carotid Plaque Instability
A study testing individualized home-based physical activity, MRI and blood sampling in people with Carotid Atherosclerosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- individualized home-based physical activity, MRI and blood sampling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2019to 21 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Individualized Home-based Physical Activity Trial on Carotid Plaque Vulnerability for Asymptomatic Patients
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.
- Conditions
- Carotid Atherosclerosis
- Being tested
- individualized home-based physical activity, MRI, blood sampling, Questionnaires, 6-minute walk test
- Keywords
- Intraplaque haemorrhage, MRI, home-based Physical activity, carotic plaque vulnerability
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized home-based physical activityDevice
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.
MRIOther
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 samplingBiological
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.
QuestionnairesOther
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
6-minute walk testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized home-based physical activity | Experimental | The 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. Receives: Device: individualized home-based physical activity; Other: MRI; Biological: blood sampling; Other: Questionnaires; Other: 6-minute walk test |
| Control group | Active comparator | The 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. Receives: Other: MRI; Biological: blood sampling; Other: Questionnaires; Other: 6-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 6
Secondary outcomes (42)
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Measured: Day 0
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Measured: Month 6
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Measured: Day 0
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Measured: Month 6
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and non-classical phenotypes (in %) will be measured by flow cytometry
Measured: Day 0
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and non-classical phenotypes (in %) will be measured by flow cytometry
Measured: Month 6
Assessment of red blood cell aggregation
Red blood cell aggregation (in %)will be measured by ektacytometry
Measured: Day 0
Assessment of red blood cell aggregation
Red blood cell aggregation (in %) will be measured by ektacytometry
Measured: Month 6
in vitro clotting formation time
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
Measured: Day 0
in vitro clotting formation time
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
Measured: Month 6
Measurement of in vitro clot lysis index
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Measured: Day 0
Measurement of in vitro clot lysis index
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Measured: Month 6
Measurement of in vitro clot firmness
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Measured: Day 0
Measurement of in vitro clot firmness
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Measured: Month 6
Assessment of plasma lipid oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Measured: Day 0
Assessment of plasma lipid oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Measured: Month 6
Assessment of plasma protein oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Measured: Day 0
Assessment of plasma protein oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Measured: Month 6
Assessment of plasma protein nitration
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Measured: Day 0
Assessment of plasma protein nitration
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Measured: Month 6
Assessment of plasma inflammatory markers
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Measured: Day 0
Assessment of plasma inflammatory markers
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Measured: Month 6
Assessment of plasma enzymes activity
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
Measured: Day 0
Assessment of plasma enzymes activity
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
Measured: Month 6
number of steps per day
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
Measured: during 2 weeks after Day 0
number of steps per day
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
Measured: during 2 weeks after Month 6
distance of the 6 minutes walking test
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
Measured: Day 0
distance of the 6 minutes walking test
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
Measured: Month 6
quadriceps maximal isometric strength
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
Measured: Day 0
quadriceps maximal isometric strength
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
Measured: Month 6
Determination of the level of physical activity
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Measured: Day 0
Determination of the level of physical activity
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Measured: Month 6
Determination of the sedentary time
Sedentary time will be evaluated by the sedentary behaviour questionnaire evaluating the total daily sitting and lying down time (in minute/day) during awaking time.
Measured: Day 0
Determination of the sedentary time
Sedentary time will be evaluated by the sedentary behaviour questionnaire evaluating the total daily sitting and lying down time (in minute/day) during awaking time.
Measured: Month 6
descriptive health state score
Health state score will be assessed using descriptive system of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire.
Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The subjects self-rate their level of severity for each dimension using a five-level (EQ-5D-5L) scale (scored from 1 to 5, 1 indicating no problem and 5 indicating extreme problem).
The health rate score correspond to the addition of each dimension score and is from 5 to 25. The lower the score, the better the health state.
Measured: Day 0
descriptive health state score
Health state score will be assessed using descriptive system of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire.
Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The subjects self-rate their level of severity for each dimension using a five-level (EQ-5D-5L) scale (scored from 1 to 5, 1 indicating no problem and 5 indicating extreme problem).
The health rate score correspond to the addition of each dimension score and is from 5 to 25. The lower the score, the better the health state.
Measured: Month 6
self-evaluated overall health status
Overall health status will be assessed using the evaluation part of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire.
The subject's self- evaluate their overall health status using the visual analogue scale (EQ-VAS).
The raw score is from 0 to 100. The higher the score, the better the perceived overall health status
Measured: Day 0
self-evaluated overall health status
Overall health status will be assessed using the evaluation part of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire.
The subject's self- evaluate their overall health status using the visual analogue scale (EQ-VAS).
The raw score is from 0 to 100. The higher the score, the better the perceived overall health status
Measured: Month 6
body mass index
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
Measured: Day 0
body mass index
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
Measured: Month 6
number of comorbidities
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined
Measured: Day 0
number of comorbidities
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start3 Dec 2019
- Primary completion12 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053166
- Sponsor's protocol ID
- 69HCL19_0345
- Other IDs
- 2019-A01543-54
- Acronym
- PACAPh
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35164816Mura 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.
PubMed 40548131
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Individualized Home-based Physical Activity Trial on Carotid Plaque Vulnerability for Asymptomatic Patients
- ClinicalTrials.gov ID
- NCT04053166
- Acronym / sponsor ID
- PACAPh / 69HCL19_0345
- Conditions
- Carotid Atherosclerosis
- Keywords
- Intraplaque haemorrhage, MRI, home-based Physical activity, carotic plaque vulnerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized home-based physical activity | Experimental | Device: individualized home-based physical activity, Other: MRI, Biological: blood sampling, Other: Questionnaires, Other: 6-minute walk testThe 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 comparator | Other: MRI, Biological: blood sampling, Other: Questionnaires, Other: 6-minute walk testThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individualized home-based physical activitySubjects 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. | Device | Individualized home-based physical activity |
| MRIAn 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). | Other | Control group, Individualized home-based physical activity |
| blood samplingBlood 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. | Biological | Control group, Individualized home-based physical activity |
| Questionnairessedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient. | Other | Control group, Individualized home-based physical activity |
| 6-minute walk testThe 6-minute walk test is a simple, individualized test that measures how fast a patient walks on a flat, hard surface for 6 minutes. | Other | Control group, Individualized home-based physical activity |
Primary outcome
decreased intensity of IPH levels measured by MRI
Time frame: Day 0
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.
decreased intensity of IPH levels measured by MRI
Time frame: Month 6
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.
42 secondary outcomes
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Time frame: Day 0
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Time frame: Month 6
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Time frame: Day 0
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Time frame: Month 6
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
Time frame: Day 0
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
Time frame: Month 6
Assessment of red blood cell aggregation
Time frame: Day 0
Assessment of red blood cell aggregation
Time frame: Month 6
in vitro clotting formation time
Time frame: Day 0
in vitro clotting formation time
Time frame: Month 6
Measurement of in vitro clot lysis index
Time frame: Day 0
Measurement of in vitro clot lysis index
Time frame: Month 6
Measurement of in vitro clot firmness
Time frame: Day 0
Measurement of in vitro clot firmness
Time frame: Month 6
Assessment of plasma lipid oxidation
Time frame: Day 0
Assessment of plasma lipid oxidation
Time frame: Month 6
Assessment of plasma protein oxidation
Time frame: Day 0
Assessment of plasma protein oxidation
Time frame: Month 6
Assessment of plasma protein nitration
Time frame: Day 0
Assessment of plasma protein nitration
Time frame: Month 6
Assessment of plasma inflammatory markers
Time frame: Day 0
Assessment of plasma inflammatory markers
Time frame: Month 6
Assessment of plasma enzymes activity
Time frame: Day 0
Assessment of plasma enzymes activity
Time frame: Month 6
number of steps per day
Time frame: during 2 weeks after Day 0
number of steps per day
Time frame: during 2 weeks after Month 6
distance of the 6 minutes walking test
Time frame: Day 0
distance of the 6 minutes walking test
Time frame: Month 6
quadriceps maximal isometric strength
Time frame: Day 0
quadriceps maximal isometric strength
Time frame: Month 6
Determination of the level of physical activity
Time frame: Day 0
Determination of the level of physical activity
Time frame: Month 6
Determination of the sedentary time
Time frame: Day 0
Determination of the sedentary time
Time frame: Month 6
descriptive health state score
Time frame: Day 0
descriptive health state score
Time frame: Month 6
self-evaluated overall health status
Time frame: Day 0
self-evaluated overall health status
Time frame: Month 6
body mass index
Time frame: Day 0
body mass index
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 35164816Mura 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.
- Results publication: PubMed 40548131Mura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individualized home-based physical activity, MRI and blood sampling in people with Carotid Atherosclerosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decreased intensity of IPH levels measured by MRI (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.