Small Vessel Disease and Cerebral Infarct Healing InErvation Via Limb Distant Adaptation

Официальное название

the Role and Mechanism of Distant Ischemic Adaptation in Improving Cognitive Impairment in Cerebral Infarction and Cerebral Small Vessel Disease

Обзор

Cerebral infarction (ischemic stroke) and cerebral small vessel disease (CSVD) represent major global causes of disability, cognitive decline, and mortality. Despite advances in reperfusion therapies, many patients experience residual neurological deficits and remain at high risk for recurrent stroke and vascular dementia. Effective adjunctive treatments that are safe, accessible, and capable of improving long-term outcomes are urgently needed. Distant ischemic adaptation (also known as remote ischemic conditioning, RIC) is a non-invasive, safe, and cost-effective intervention that induces endogenous protection against ischemic injury by applying brief, intermittent ischemia to a remote limb. While several large-scale clinical trials (e.g., RICAMIS, RECAST) have demonstrated promising neuroprotective effects of RIC in acute ischemic stroke, results remain inconsistent across studies, particularly in patients with CSVD. Key challenges include the lack of standardized RIC protocols and the absence of specific biomarkers to predict treatment response and elucidate underlying mechanisms. To address these gaps, this study aims to identify potential effector proteins and specific biomarkers that mediate the therapeutic effects of RIC in patients with cerebral infarction and CSVD. By collecting and analyzing serum samples from RIC-treated patients and controls, we seek to uncover molecular mechanisms underlying RIC-induced neuroprotection and cognitive preservation. The findings may establish a theoretical foundation for optimizing RIC therapy, provide novel drug targets, and ultimately improve clinical outcomes for patients suffering from ischemic stroke and small vessel disease.

Вмешательства

• Устройство Medical-grade ischemic preconditioning training instrument
  The remote ischemic conditioning (RIC) intervention consists of two sessions per day, with 5 cycles per session (each cycle comprising 5 minutes of inflation followed by 5 minutes of deflation), performed alternately on both upper arms. The inflation pressure is set at baseline systolic blood pressure + 20 mmHg, gradually increased up to a maximum of 200 mmHg. If the patient experiences discomfort, the pressure may be appropriately reduced to allow adaptation, then gradually increased again. At
• Другое Standard Treatment
  Standard Treatment

Первичные конечные точки

• Change in White Matter Hyperintensity (WMH) Volume on Brain MRI [Срок оценки: Baseline, Month 3]
• Change in National Institutes of Health Stroke Scale (NIHSS) Score [Срок оценки: Baseline, Month 1, Month 3]
• Change in Cognitive Function (MoCA and MMSE Scores) [Срок оценки: Baseline, Month 1, Month 3]

Вторичные конечные точки (3)

• Serum Levels of Inflammatory and Neuroprotective Biomarkers [Срок оценки: Baseline, Month 1, Month 3]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Throughout the 3-month intervention period]
• Compliance Rate with RIC Intervention [Срок оценки: Throughout the 3-month intervention period]

Критерии участия

Критерии включения

• Aged between 50 and 65 years.
• Definite diagnosis of cerebral infarction or cerebral small vessel disease-related cerebral infarction confirmed by brain MRI or other imaging examinations.
• Ability to complete the 3-month follow-up and RIC intervention (for the experimental group).
• Few underlying comorbidities, limited to hypertension and hyperlipidemia; clear consciousness with the ability to provide informed consent.
• Modified Rankin Scale (mRS) score < 2, with no severe cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA).
• Enrolled within 48 hours after the onset of stroke symptoms (i.e., from the time the patient was last known to be well, during the acute phase).

Критерии исключения

• Complicated with diabetes mellitus, smoking history, or other metabolic disorders.
• Complicated with other types of stroke (e.g., cardioembolic stroke, large artery atherosclerotic stroke, etc.).
• Presence of severe cognitive impairment, depression, or other psychiatric or neurological disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• 2ndAffiliated Hospital, School of Medicine, Zhejiang Universit, Hangzhou, Zhejiang 310000 — Ханчжоу

Идентификаторы

NCT: NCT07503301 · 2026-0150

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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