Status:
COMPLETED
Individualized Physical Activity and Carotid Plaque Instability
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Carotid Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 endarterecto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04053166
Start Date
December 3 2019
End Date
September 21 2022
Last Update
December 19 2025
Active Locations (1)
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1
Hôpital Louis Pradel
Bron, France, 69500