Triage of Patients Presenting Beyond 24 Hours With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late)

NCT06200753 | Recruiting DMC

• 1 other identifier: TJHH-2023-WM28
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to create a comprehensive, multi-center, TRACK-LVO registry-linked cohort of consecutive patients with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO) and presenting to each participating center beyond 24 hours from last known well, who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).

Conditions

Endovascular Thrombectomy; Large Vessel Occlusion; Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke, Endovascular Therapy,

Outcome Measures

Primary Outcomes (2)

• Modified ranking scale (mRS) at 90 days

  A 0-6 scale running from perfect health without symptoms to death.

  90 days

• symptomatic intracranial hemorrhage

  any hemorrhagic transformation on subsequent imaging associated with a neurological decline of at least 4 points increase on the NIHSS score

  72 hours

Secondary Outcomes (3)

• National Institutes of Health Stroke Scale (NIHSS) scores at 90 days

  1, 3, 5 (or discharge), 7 (or discharge) and 90 days

• Occurrence of periprocedural complications

  72 hours

• EuroQol five dimensions questionnaire (EQ-5D)

  1 year

Study Arms (2)

Endovascular therapy

Procedure: Mechanical Thrombectomy

Best medical treatment

Procedure: Mechanical Thrombectomy

Interventions

Mechanical Thrombectomy PROCEDURE

Mechanical Thrombectomy: A stroke treatment method involving the use of a device to extract a blood clot from the blood vessels, restoring blood flow and reducing brain damage. Ischemic Post-conditioning: After thrombectomy, a procedure involving inflating and deflating a balloon in situ for four cycles of 2 minutes each, reducing reperfusion injury and minimizing neural damage. Selective Hypothermia: Administering cold saline either intra-arterially or within the cerebral sinus to lower brain temperature, mitigating ischemia-induced injury.

Also known as: Ischemic post-conditioning, Selective Hypohermia

Best medical treatment; Endovascular therapy

Eligibility Criteria

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

Study Population

Acute stroke patients with large vessel occlusion and presenting beyond 24 hours from last known well

You may qualify if:

• Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
• Presenting beyond 24 hours from last known well;
• Ischemic stroke confirmed by head CT or MRI;
• Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
• Patients receiving either endovascular therapy or best medical treatment.

You may not qualify if:

• Presence of any forms of cerebral hemorrhage on CT/MR at admission.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300070, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

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

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 11, 2024
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)