Augmenting Cerebral Blood Flow in Acute Ischemic Stroke

Официальное название

Augmenting Cerebral Blood Flow Using a Novel Combined Treatment Approach in Patients With Ischemic Stroke: Protocol Development

Обзор

The most common type of stroke is ischemic (lack of blood flow to the brain due to a clot blocking a blood vessel). Time is brain and an average of 1.9 million brain nerve cells per minute are destroyed in patients experiencing a typical LVO. The main goal of treatment is to help restore blood flow as quickly as possible and prevent brain tissue and cell death. Acute treatments like clot-busting medication or clot removal by wire are standard of care but are available in comprehensive stroke centers in a few urban centers. Often, patients need to be transferred to these centers via ground or air ambulance, sometimes over hours, and no active treatment can be provided during these transfers. Enhancing or increasing blood flow to the brain is associated with good outcomes in stroke. This study involves an innovative approach combining two treatment interventions - Remote ischemic conditioning (arms) and Air compression therapy (legs, applied simultaneously to all four limbs, that may help improve blood flow to the brain. Remote Ischemic Conditioning is a type of treatment delivered with the help of a regular blood pressure machine. This does not involve any drug. A typical treatment involves the application of a blood pressure cuff followed by brief sessions of compressions and relaxation on the arm muscles, much akin to blood pressure measurement, but for 5 min. It leads to a transient safe state of less blood flow in arm muscles which initiates the release of molecules and signals transmitted by blood. These signals may then go on to improve blood flow in the brain. Air Compression is delivered by a commercially available device (Normatech Elite). They are inflatable sleeves resembling puffy thigh-high boots that deliver compressive pulses stimulating blood flow in the legs, in a graded manner from the ankles to the thighs. We believe this air compression device may help improve and divert blood flow to stroke-affected areas in the brain.

Вмешательства

• Устройство Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb
  Arm Remote Ischemic Conditioning (4 cycles) plus Pneumatic Compression lower limb (100 mmHg for 1 hour)

Первичные конечные точки

• Feasibility of intervention completion [Срок оценки: End of intervention at 1 hour]

Вторичные конечные точки (3)

• Tolerability of intervention [Срок оценки: End of intervention at 1 hour]
• Change in cortical oxygenation content [Срок оценки: End of intervention at 1 hour]
• Feasibility of ease of delivery of the intervention [Срок оценки: End of intervention at 1 hour]

Критерии участия

Критерии включения

• Age > 18 years
• Both male and female participants will be included
• History of Stroke Symptoms
• Baseline modified Rankin scale score < 2
• Participant or substitute decision-maker able to provide informed consent.

Критерии исключения

• Injury to the upper arms, lower limbs (from ankles to thighs), or any other musculoskeletal disability/pain that precludes tolerating RIC and/or Pneumatic compression therapy.
• History of dermatological conditions affecting application of RIC cuff with tissue perfusion sensor and pneumatic compression boots.
• History of peripheral arterial disease
• Treatment of ongoing malignancy with expected survival < 6 months
• Presence of hypertensive urgency and emergency
• Presence of hemodynamic instability and ongoing pulmonary edema
• Presence of clinical or imaging signs of raised intracranial, intrathoracic, and /or intra-abdominal pressure.
• Presence of ongoing systemic infection with antibiotic therapy
• Pregnant and lactating women
• Participant not part of other clinical intervention trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06911385 · Pro00139595 · RES0060767

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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