Augmenting Cerebral Blood Flow in Acute Ischemic Stroke

University of Alberta

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Stroke

Treatments: Device: Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb

Study type: Interventional

Funder types: Other

Identifiers

NCT06911385

Pro00139595

RES0060767 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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.
2. History of dermatological conditions affecting application of RIC cuff with tissue perfusion sensor and pneumatic compression boots.
3. History of peripheral arterial disease
4. Treatment of ongoing malignancy with expected survival < 6 months
5. Presence of hypertensive urgency and emergency
6. Presence of hemodynamic instability and ongoing pulmonary edema
7. Presence of clinical or imaging signs of raised intracranial, intrathoracic, and /or intra-abdominal pressure.
8. Presence of ongoing systemic infection with antibiotic therapy
9. Pregnant and lactating women
10. Participant not part of other clinical intervention trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

Remote ischemic conditioning plus Pneumatic Compression

Experimental group

Treatment:

Device: Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb