Thrombus Imaging and Treatment Analytics in Neurology (Titan)

June 30, 2024 updated by: Jinhao Lyu, Chinese PLA General Hospital
In the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to investigate the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral ischemic stroke resulting from thrombosis causes high disability and mortality. There are few biomarkers to evaluate arterial thrombophilia until now. Previous studies have demonstrated that atherosclerotic plaque rupture and erosion are major etiologies initiating thrombosis. Based on previous works targeting the role of plaque and blood flow in cerebrovascular disease, in the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to explore the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment. The study's objective was to solve the challenges in the mechanism of thrombus features and the outcome of recanalization therapy, thus helping improve the primary and secondary prevention of cerebrovascular disease.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants who are confirmed to have extracranial and/or intracranial artery occlusion

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Extracranial and/or intracranial artery occlusion confirmed by angiography
  • Available for magnetic resonance high-resolution vessel wall imaging
  • Written informed consent obtained

Exclusion Criteria:

  • Extracranial and/or intracranial artery mild to moderate stenosis
  • Pregnant women
  • Restenosis or occlusion after artery stenting placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Successful Recanalization
Time Frame: 1-3 Years
Antegrade blood flow through the recanalized portion was assessed by thrombolysis in myocardial infarction (TIMI) score or thrombolysis in cerebral infarction (TICI) score. TIMI≥2 or TICI≥2b was defined as successful recanalization.
1-3 Years
Ischemic Stroke Occurrence
Time Frame: 1-3 Years
Ischemic stroke occurrence during follow-up period which was confirmed by neuroimaging
1-3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: 1-3 Years
hemorrhagic or ischemic stroke after recanalization treatment
1-3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 30, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301Titan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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