Study of Cerebral Venous System in Acute Ischemic Stroke Patients Receiving Reperfusion Therapy

NCT03838289 | Unknown

• 1 other identifier: cerebral vein
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The VAST study is a single-center prospective observational study that enrolled individuals with acute ischemic stroke (AIS) within 24 hours onset. The patients will receive neurological examination, multimodal computed tomographic perfusion (CTP) or multimodal magnetic resonance perfusion (MRP) before reperfusion therapy. The hypoperfusion volume, ischemic core volume, brain edema, cerebral arterial collaterals will be evaluated on baseline brain image. The status of cerebral venous system (CVs) including superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein will be evaluated in phases of reconstructed imaging from CTP/MRP. The investigators will explore the venous markers for prognosis of AIS patients who received reperfusion therapy, and find the role of venous system in reperfusion injury.

Conditions

Stroke; Cerebral Venous System; Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• Prognosis

  modified Rankin Scale at 90 days: * 0 = No symptoms; * 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; * 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; * 3 = Moderate disability. Requires some help, but able to walk unassisted; * 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; * 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; * 6 = Dead. A score of \>2 means poor outcome.

  90 days

Secondary Outcomes (2)

• Brain edema

  24-hour

• Hemorrhage transformation

  24-hour

Study Arms (2)

Individuals with absent filling of CVs

Individuals with absent filling of following CVs: superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein

Radiation: multimodal magnetic resonance imaging or computed tomography

individuals without any absent filling of CVs

Individuals without any absent filling of following CVs: superficial middle cerebral vein, vein of Labbe, vein of Trolard, Sphenoid sinus, thalamostriate vein, Internal cerebral vein, Rosenthal's vein

Radiation: multimodal magnetic resonance imaging or computed tomography

Interventions

multimodal magnetic resonance imaging or computed tomography RADIATION

multimodal magnetic resonance imaging including T1 Flair,T2 Flair, magnetic resonance angiography (MRA), perfusion-weighted imaging (PWI), diffusion-weighted imaging (DWI), enhanced gradient echo T2 star weighted angiography (ESWAN); multimodal computed tomography including non-contrast CT, volume perfusion CT

Also known as: blood samples collection, neurological examination

Individuals with absent filling of CVs; individuals without any absent filling of CVs

Eligibility Criteria

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

Study Population

acute ischemic stroke patients

You may qualify if:

• receive reperfusion therapy within 24 hours after onset;
• undergo multimodal magnetic resonance computed tomography before reperfusion therapy and CTP or magnetic resonance perfusion at 24 hours after reperfusion therapy;

You may not qualify if:

• Contraindication to imaging with contrast agents;
• Without provision of informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hosipital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Stroke; Reperfusion Injury

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Min Lou, Ph.D

CONTACT

13958007213; loumingxc@vip.sina.com

Study Design

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

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 12, 2019
• Study Start: March 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)