Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis

NCT04847752 | Recruiting

• 1 other identifier: TJID-20210404TDS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center prospective cohort study of predictive factors related to prognosis of ischemic stroke due to large-artery atherosclerosis. From March 1, 2021 to December 31, 2026, 1000 patients with ischemic stroke due to large-artery atherosclerosis who are admitted to the Department of Neurology or Neurosurgery, Tongji Hospital are going to be recruited. Detailed clinical data in emergency room and in-hospital will be obtained from the medical record reviews, and the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) score will be done by certified neurologists to assess the severity of the disease in acute stage and treatment outcome during the follow-up. All cases will undergo routine blood tests, brain magnetic resonance imaging (MRI) and cerebral vascular examination, such as TCD, CTA, HRMR or DSA. The investigators will analyze the in-hospital factors that could predict the outcome to provide more evidence-based suggestions in the treatment and prognosis of atherosclerotic ischemic cerebrovascular disease.

Conditions

Ischemic Stroke; Large-Artery Atherosclerosis (Embolus/Thrombosis)

Outcome Measures

Primary Outcomes (2)

• all-cause mortality

  Death during the follow-up in every single reason

  3-6 months after onset.

• Stroke of any kind

  Brain CT or MRI scans will be used to measure whether there is any kind of stroke, including TIA, ischemic stroke, and hemorrhage

  3-6 months after onset.

Secondary Outcomes (3)

• Rehospitalization

  1 month to 24 months after onset.

• National Institute of Health stroke scale (NIHSS score)

  1 month to 24 months after onset.

• modified Ranking score (mRS)

  1 month to 24 months after onset.

Interventions

carotid artery stenting PROCEDURE

common treatments for carotid artery stenosis

Also known as: CAS

carotid endarterectomy PROCEDURE

common treatments for carotid artery stenosis

Also known as: CEA

Aspirin DRUG

the dosage and duration

Also known as: ASP

Clopidogrel DRUG

the dosage and duration

Also known as: plavix

Anticoagulant DRUG

the dosage and duration

Also known as: warfarin, rivaroxaban, dabigatran, any other anticoagulant therapy

Statin DRUG

the dosage and duration

Also known as: atorvastatin, rosuvastatin, any other statin drugs

PCSK9 inhibitor DRUG

the dosage and duration

Also known as: Evolocumab, Alirocumab, any other PCSK9 inhibitors

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ischemic stroke due to large-artery atherosclerosis admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from March 1, 2021 - December 31, 2026

You may qualify if:

• Ischemic stroke due to large-artery atherosclerosis has been proved by clinical symptoms and imaging examinations.
• Symptomatic superior arch stenosis \>50%
• Asymptomatic superior arch stenosis was \>70%
• written informed consent was obtained from patients or their surrogates before enrollment.

You may not qualify if:

• Brain CT or MRI showing cerebral hemorrhage (excluded ischemic stroke with hemorrhage transformation)
• With severe systemic disease, are expected to survive \< 3 months
• Patients will not able to provide continuous follow-up information

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

carotid plaque fixed tissues and plasma

MeSH Terms

Conditions

Ischemic Stroke; Embolism; Thrombosis

Interventions

Endarterectomy, Carotid; Aspirin; Clopidogrel; Anticoagulants; Warfarin; Rivaroxaban; Dabigatran; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium; evolocumab; alirocumab

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Morpholines; Oxazines; Benzimidazoles; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Pyrimidines

Study Officials

• Dai-Shi Tian, Dr.

  Tongji Hospital

  STUDY CHAIR

• Chuan Qin, Dr.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Jun Xiao, Dr.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Ke Shang, Dr.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dai-Shi Tian, Dr.

CONTACT

86-27-83663337; tiands@tjh.tjmu.edu.cn

Chuan Qin, Dr.

CONTACT

86-27-83663337; qinchuan712@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 12 months after publication
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

CN (1)