Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT04053166
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04053166
Study Brief:
Protocol Section:
NCT04053166