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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTianjin Huanhu Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mechanical Thrombectomy

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Endovascular therapy1 intervention
Group B: Best medical treatment1 intervention

Trial outcomes

Primary outcomes

1

Modified ranking scale (mRS) at 90 days

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

Time frame
90 days
2

symptomatic intracranial hemorrhage

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

Time frame
72 hours

Secondary outcomes

1

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

The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Time frame
1, 3, 5 (or discharge), 7 (or discharge) and 90 days
2

Occurrence of periprocedural complications

Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.

Time frame
72 hours
3

EuroQol five dimensions questionnaire (EQ-5D)

The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

Time frame
1 year

Other outcomes

Sponsors and contacts

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