Associations of Carotid Plaque Characteristics With Brain Perfusion and Cognitive Function in Patients Undergoing CEA

NCT04955015 | Unknown

• 1 other identifier: M2019292
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is one of the leading causes of death and disability-adjusted life-years worldwide. Carotid high-risk atherosclerotic plaques are considered to be one of the major sources of ischemic stroke. The present study aimed to investigate the relationship of carotid plaque characteristics with brain perfusion and cognitive function in patients undergoing carotid endarterectomy.

Conditions

Atherosclerosis of Artery; Carotid Endarterectomy

Keywords

atherosclerosis; carotid endarterectomy; perfusion; cognition

Outcome Measures

Primary Outcomes (2)

• brain perfusion

  perioperative brain perfusion and changes of brain perfusion in patients underging CEA

  From preoperative to 24 months after operation (CEA)

• cognitive function

  perioperative cognitive function and cognitive changes in patients underging CEA

  From preoperative to 24 months after operation (CEA)

Study Arms (1)

patients

patients with caotid atherosclerosis refering to carotid endarterectomy

Procedure: carotid endarterectomy

Interventions

carotid endarterectomy PROCEDURE

patients with carotid atherosclerosis refering to CEA

patients

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with carotid atherosclerosis refering to CEA in our hospital

You may qualify if:

• Over 30 years old;
• The patients with symptomatic (\>50%) or asymptomatic carotid stenosis (\> 70%) measured by computed tomography angiography (CTA) or B-mode ultrasonography
• CEA operation will be performed in our hospital.

You may not qualify if:

• The history of CEA operation in the last 3 months;
• Diseases (AF, valve diseases, etc.) that may cause cardiac thrombosis;
• Contraindications of MR examination (vascular stent implantation, pacemaker, metal or magnetic plants in vivo, claustrophobia, etc.) were found;
• Contraindications of contrast agents: such as renal failure, iodine or gadolinium contrast agent allergy;
• Having heart or respiratory failure;
• Serious consciousness disorder (coma, etc.);
• Brain tumor;
• Acute cerebral hemorrhage;
• Pregnant women or planned pregnancies in the past 2 years;
• Who does not agree to sign the informed consent.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Huishu Yuan, Dr.

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Ran Huo, Dr.

CONTACT

010-82264374; ransmile216@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: September 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2023
• Last Updated: July 8, 2021

Record last verified: 2021-06

Locations

CN (1)