Individualized Physical Activity and Carotid Plaque Instability (PACAPh)

December 13, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hôpital Louis Pradel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individualized home-based physical activity
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.
Device: individualized home-based physical activity
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.
Other: MRI
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).
Biological: blood sampling
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.
Other: Questionnaires
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
Other: 6-minute walk test
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.
Active Comparator: Control group
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.
Other: MRI
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).
Biological: blood sampling
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.
Other: Questionnaires
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
Other: 6-minute walk test
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Time Frame: Day 0
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Day 0
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Time Frame: Month 6
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Month 6
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Time Frame: Day 0
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Day 0
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Time Frame: Month 6
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Month 6
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
Time Frame: Day 0
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
Day 0
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
Time Frame: Month 6
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
Month 6
Assessment of red blood cell aggregation
Time Frame: Day 0
Red blood cell aggregation (in %)will be measured by ektacytometry
Day 0
Assessment of red blood cell aggregation
Time Frame: Month 6
Red blood cell aggregation (in %) will be measured by ektacytometry
Month 6
in vitro clotting formation time
Time Frame: Day 0
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
Day 0
in vitro clotting formation time
Time Frame: Month 6
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
Month 6
Measurement of in vitro clot lysis index
Time Frame: Day 0
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Day 0
Measurement of in vitro clot lysis index
Time Frame: Month 6
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Month 6
Measurement of in vitro clot firmness
Time Frame: Day 0
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Day 0
Measurement of in vitro clot firmness
Time Frame: Month 6
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Month 6
Assessment of plasma lipid oxidation
Time Frame: Day 0
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Day 0
Assessment of plasma lipid oxidation
Time Frame: Month 6
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Month 6
Assessment of plasma protein oxidation
Time Frame: Day 0
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Day 0
Assessment of plasma protein oxidation
Time Frame: Month 6
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Month 6
Assessment of plasma protein nitration
Time Frame: Day 0
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Day 0
Assessment of plasma protein nitration
Time Frame: Month 6
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Month 6
Assessment of plasma inflammatory markers
Time Frame: Day 0
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Day 0
Assessment of plasma inflammatory markers
Time Frame: Month 6
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Month 6
Assessment of plasma enzymes activity
Time Frame: Day 0
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
Day 0
Assessment of plasma enzymes activity
Time Frame: Month 6
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
Month 6
number of steps per day
Time Frame: during 2 weeks after Day 0
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
during 2 weeks after Day 0
number of steps per day
Time Frame: during 2 weeks after Month 6
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
during 2 weeks after Month 6
distance of the 6 minutes walking test
Time Frame: Day 0
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
Day 0
distance of the 6 minutes walking test
Time Frame: Month 6
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
Month 6
quadriceps maximal isometric strength
Time Frame: Day 0
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
Day 0
quadriceps maximal isometric strength
Time Frame: Month 6
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
Month 6
Determination of the level of physical activity
Time Frame: Day 0
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Day 0
Determination of the level of physical activity
Time Frame: Month 6
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Month 6
Determination of the sedentary time
Time Frame: Day 0
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.
Day 0
Determination of the sedentary time
Time Frame: Month 6
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.
Month 6
descriptive health state score
Time Frame: Day 0

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.
Day 0
descriptive health state score
Time Frame: Month 6

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.
Month 6
self-evaluated overall health status
Time Frame: Day 0

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
Day 0
self-evaluated overall health status
Time Frame: Month 6

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
Month 6
body mass index
Time Frame: Day 0
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
Day 0
body mass index
Time Frame: Month 6
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
Month 6
number of comorbidities
Time Frame: Day 0
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined
Day 0
number of comorbidities
Time Frame: Month 6
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL19_0345
  • 2019-A01543-54 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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