Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke

Официальное название

Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke (RICAS): a Prospective, Randomized, Blind Endpoint, Multicenter Study

Обзор

The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology.

Подробное описание

Stroke is the second leading cause of death and the third leading cause of death and disability combined in the world. The remote ischemic preconditioning (RIC) procedure is low-cost with excellent properties of safety, tolerability and feasibility in both AIS and cardiovascular diseases. In this study, we aim to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology. The RICAS study is a prospective, randomized, blind endpoint, multicenter study. Eligible patients with ischemic stroke of anterior circulation with large artery atherosclerosis etiology, poor collateral compensation, and more than 1 month of the symptom onset, are randomly assigned into the experimental group and control group with a ratio of 1:1. The patients in experiment group will receive treatment with RIC for 1 year as an adjunct to guideline-based treatment, while patients in control group only receive guideline-based treatment. The primary outcome is proportion of collateral status improvement, which is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization. The safety outcomes include RIC-related adverse events. A maximum of 300 patients (150 participants per group) are required to test the superiority hypothesis with 80% power (using a two-sided α = 0.05) to detect the 15% difference. The primary endpoint will further be stratified by age, gender, inclusion event (acute ischemic stroke ore transient ischemic stroke), tandem lesion, history of hypertension, hypercholesterolemia, diabetes mellitus, ischemic stroke, transient ischemic attack, and myocardial infarction. This study will provide the direct evidence for improvement of collateral status by chronic RIC treatment.

Вмешательства

• Устройство Remote ischemic preconditioning
  The patients in experiment group will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg) for 1 year as an adjunct to guideline-based treatment.

Первичные конечные точки

• The proportion of collateral status improvement. [Срок оценки: 12 months]

Вторичные конечные точки (6)

• The influence of RIC to neurological functions [Срок оценки: 12 months]
• Recurrence of nonfatal ischemic stroke in 12 months [Срок оценки: 12 months]
• Composite vascular events [Срок оценки: 12 months]
• Influence on heart function [Срок оценки: 12 months]
• Influence on kidney function [Срок оценки: 12 months]
• RIC-related adverse events [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 1\. Age over 40 years old;
• 2\. Diagnosed with ischemic stroke (including TIA and cerebral infarction), with onset time of more than 1 month;
• 3\. Culprit arteries are the large arteries of the anterior circulation with atherosclerotic stenosis (≥50%) or occlusion;
• 4\. ASITN/SIR collateral circulation of 0-3 based on DSA evaluation;
• 5\. First onset or prior onset with no significant sequelae (mRS ≤ 2);
• 6\. Those who are not expected to undergo angioplasty within 12 months (judged by the doctor or decided by patients and/or their representatives);
• 7\. The availability of informed consent.

Критерии исключения

• 1\) Patients with severe infection or serious diseases such as liver, kidney, hematopoietic system, endocrine system, etc.;
• 2\) Patients with a history of stroke and severe sequelae (mRS≥3);
• 3\) arterial stenosis due to aortic dissection, moyamoya disease; Any known vasculitic disease; herpes zoster, varicella-zoster or other viral infections with vascular lesions; neurosyphilis; other intracranial infections; any intracranial artery stenosis associated with hypercytosis of cerebrospinal fluid; radiation-induced vascular lesions; myofiber dysplasia; sickle cell disease; neurofibromas; benign vascular lesions of the central nervous system; postpartum vascular disease; stenosis of the intracranial arteries due to vasospasm or thrombosm;
• 4\) Uncontrolled severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110 mmHg after drug treatment) ;
• 5\) Subclavian artery stenosis ≥50% or subclavian artery steal syndrome;
• 6\) Patients with intracranial hemorrhage (parenchymal hemorrhage, subarachnoid hemorrhage, subdural/epidural hemorrhage) within 90 days before enrollment;
• 7\) Intracranial tumor, arteriovenous malformation, or aneurysm;
• 8\) Patients with severe hematologic diseases or severe coagulation abnormalities;
• 9\) Retinal hemorrhage or visceral hemorrhage within 30 days;
• 10\) Those who are expected to undergo major surgery (including femoral artery, cardiac, aortic or carotid artery surgery) within 30 days before enrollment or within 12 months after enrollment;
• 11\) Those who have received stent implantation, angioplasty or other related medical devices for the target diseased blood vessels, or those who are expected to undergo the above treatments within 12 months after enrollment;
• 12\) Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.
• 13\) Damage and lesions in the cerebral veins;
• 14\) Pregnant or lactating women;
• 15\) Those who are participating in other clinical trials within 3 months;
• 16\) Life expectancy is less than 1 year
• 17\) Patients not suitable for this clinical studies considered by researcher

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• General Hospital of Northern Theater Command — Шэньян

Публикации

• Zhao ZA, Lv Y, Chen HS. Effect of RICAS (Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke): Rationale and Design. J Am Heart Assoc. 2025 Mar 18;14(6):e038570. doi: 10.1161/JAHA.124.038570. Epub 2025 Feb 19. PMID 39968799

Идентификаторы

NCT: NCT06170944 · Y(2023)169

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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