Plaque Calcium Characterization and Ruptured Plaques

NCT03849521 | Unknown

• 1 other identifier: 201703
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, ultrashort echo time (UTE) MR, which allows detection of the ultrashort T2 components, has been used to image plaque calcification in ex vivo carotid and coronary arteries. The results demonstrated that UTE images are able to identify plaque calcification and enables accurate quantification of calcium volumes. However, gadolinium-based contrast agents during in vivo CMR could not be performed in these ex vivo study. Agnese et al. believed that calcifications with 18F-NaF PET uptake might be considered to represent dormant areas where on-going mineralization, which is a key sign to identify and localise ruptured and high risk coronary plaque. We, therefore, hypothesize that enhanced carotid calcification presented by UTE MR may be a critical sign for symptomatic patients. In this study, we will investigate the feasibility of enhanced UTE MR in human carotid arteries in vivo. Furthermore, we analyzed the correlation between UTE MR and microcalcification of in the carotid plaques. Based on the diagnostic ability of enhanced UTE MR for microcalcification, we will investigate the potential of enhanced calcification to distinguish symptomatic from asymptomatic patients with carotid atherosclerosis and research the prognostic ability of enhance calcufication in UTE MR.

Conditions

Vulnerable Atherosclerotic Plaque

Keywords

Atherosclerosis; Calcium; MR

Outcome Measures

Primary Outcomes (1)

• Symptoms attributable to the carotid artery disease

  Clinical assessment at baseline using both patient interview and chart review documented presence or absence of symptoms (symptomatic and asymptomatic patients, respectively) attributable to the carotid artery disease, such as transient ischemic attack or cerebrovascular accident in the distribution of the diseased artery and absence of other source of embolism.

  3 years

Study Arms (2)

Asymptomatic group

Group with asymptomatic patients with carotid atherosclerosis.

Diagnostic Test: MRI

Symptomatic group

Group with symptomatic patients with carotid atherosclerosis.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Enhanced carotid calcification presented by UTE MR.

Asymptomatic group; Symptomatic group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sixty patients referred for carotid endarterectomy or stent were prospectively enrolled.Patients gave written informed consent to participate in this Institutional Review Board-approved human subjects investigation. Clinical assessment at baseline using both patient interview and chart review documented presence or absence of symptoms (symptomatic and asymptomatic patients, respectively) attributable to the carotid artery disease, such as transient ischemic attack or cerebrovascular accident in the distribution of the diseased artery and absence of other source of embolism.

You may qualify if:

• Patients referred for carotid endarterectomy or stent were prospectively enrolled.

You may not qualify if:

• Patients with ferromagnetic metal, active implants such as pacemakers, aneurysm clips, known claustrophobia, and those who were unable to provide informed consent were excluded from enrollment.

Sponsors & Collaborators

• Li Min: lead

Study Sites (1)

Min Li

Jinan, Shandong, 250031, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The carotid plaques of patient undergoing carotid endarterectomy will be retented. Furthermore, the histopathological features as well as bone-like genetic program will be analyzed systematically.

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zhen Yang, M.D.

CONTACT

18615658796; taianyangzhen@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)