Remote Ischemic Conditioning Combined With Endovascular Stenting for Symptomatic Intracranial Atherosclerotic Stenosis

NCT05653505 | Not Yet Recruiting DMC

• 1 other identifier: TJHH-2022-WM11
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this registry is to evaluate the safety and efficacy of RIC for patients with symptomatic intracranial atherosclerotic stenosis (sICAS) undergoing endovascular therapy.

Conditions

Intracranial Arteriosclerosis; Ischemic Preconditioning; Endovascular Procedures

Keywords

Remote Ischemic Conditioning; Endovascular Stenting; Symptomatic Intracranial Atherosclerotic Stenosis

Outcome Measures

Primary Outcomes (2)

• The presence of ≥1 new brain lesions on DWI within 48 hours after endovascular stenting

  A new brain lesion was diagnosed if increased signal intensity was visible on DWI with correspondent decreased signal on apparent diffusion coefficient.

  48 hours

• Incidence of clinical adverse events within 12 months after endovascular stenting

  Clinical adverse events include ischemic stroke, TIA, acute myocardial infarction,hemorrhagic stroke, hyperperfusion syndrome, and death.

  12 months

Secondary Outcomes (4)

• Number of new brain lesions on DWI within 48 hours after endovascular stenting

  48 hours

• The volume of new brain lesions on DWI within 48 hours after endovascular stenting

  48 hours

• National Institutes of Health Stroke Scale (NIHSS) scores at 12 months

  12 months

• Modified Rankin Scale (mRS) scores at 12 months

  12 months

Study Arms (2)

Endovascular therapy

According to current guideline recommendations, patients enrolled in this cohort will receive standardized perioperative management, endovascular therapy, and postoperative medical therapy.

Endovascular therapy+Remote ischemic conditioning

Patients enrolled in this cohort will receive the same treatment as those in the endovascular therapy alone cohort as well as additional remote ischemic conditioning treatment. Remote ischemic conditioning treatment protocol: RIC will be applied immediately after admission to the integrated neurovascular ward and the treatment continues until the patient is discharged, Once the patient is discharged, the choice of whether to continue RIC treatment depends on the patient's preference. RIC was induced through a standard blood pressure cuff placed around the non-paretic arm. The protocol includes 5 cycles of intermittent manually induced upper limb ischemia, alternating 5 minutes of inflation (20mmHg above systolic blood pressure), and 5 minutes of deflation twice a day.

Other: Remote Ischemic Conditioning

Interventions

Remote Ischemic Conditioning OTHER

Remote ischaemic conditioning (RIC) refers to a process whereby periods of intermittent ischemia, typically via the cyclical application of a blood pressure cuff to a limb at above systolic pressure, confers systemic protection against ischemia in spatially distinct vascular territories.

Endovascular therapy+Remote ischemic conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.

You may qualify if:

• Patient admitted from Jan. 1st 2023 to Jan. 1st 2025;
• Age ≥ 18;
• Intracranial atherosclerosis stenosis measured as ≥70% by digital subtraction angiography or by other noninvasive methods, such as transcranial doppler, computed tomography angiography, or magnetic resonance angiography;
• A history of stroke/transient ischemic attack attributed to ICAS;
• Verbal and written informed consent is provided at the time of admission by patients or their legally authorized representatives.

You may not qualify if:

• Stenosis of other causes;
• Prior ipsilateral stroke with residual deficits;
• Uncontrolled hypertension (defined as systolic blood pressure ≥200 mm Hg despite medications at enrollment);
• Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion).

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

TianJinHH

Tianjin, Tianjin Municipality, 300222, China

Location

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ming Wei, PhD

  Tianjin Huanhu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Wei, PhD

CONTACT

13502182903; drweiming@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

CN (1)