Effect of an Individualized Home-based Physical Activity Trial on Carotid Plaque Vulnerability for Asymptomatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- decreased intensity of IPH levels measured by MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two experienced observers will blindly read the MRI scans.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: individualized home-based physical activity (Device)
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.
干预措施: MRI (Other)
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.
干预措施: blood sampling (Biological)
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.
干预措施: Questionnaires (Other)
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.
干预措施: 6-minute walk test (Other)
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.
干预措施: MRI (Other)
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.
干预措施: blood sampling (Biological)
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.
干预措施: Questionnaires (Other)
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.
干预措施: 6-minute walk test (Other)
结局指标
主要结局
decreased intensity of IPH levels measured by MRI
时间窗: 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.
次要结局
- Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)(Month 6)
- Assessment of red blood cell aggregation(Month 6)
- Measurement of in vitro clot firmness(Month 6)
- Assessment of plasma enzymes activity(Month 6)
- number of steps per day(during 2 weeks after Month 6)
- self-evaluated overall health status(Month 6)
- in vitro clotting formation time(Month 6)
- Measurement of in vitro clot lysis index(Month 6)
- Assessment of plasma lipid oxidation(Month 6)
- Assessment of plasma protein nitration(Month 6)
- Assessment of plasma inflammatory markers(Month 6)
- number of comorbidities(Month 6)
- Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)(Month 6)
- descriptive health state score(Month 6)
- Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)(Month 6)
- quadriceps maximal isometric strength(Month 6)
- Determination of the sedentary time(Month 6)
- Assessment of plasma protein oxidation(Month 6)
- distance of the 6 minutes walking test(Month 6)
- Determination of the level of physical activity(Month 6)
- body mass index(Month 6)