Augmenting Cerebral Blood Flow in Acute Ischemic Stroke | NCT06911385

Studies
Augmenting Cerebral Blood Flow in Acute Ischemic Stroke

NCT06911385

Sponsor

University of Alberta

Status

Not yet recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

150Estimated

Phase

Phase 1Phase 2

Conditions

Stroke

Interventions

Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RES0060767	Other Grant/Funding Number	Health Everywhere: Building an ecosystem of innovation in eHealth and mHealth in Alberta

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2026Estimated

Primary Completion Date

May 31, 2027Estimated

Completion Date

May 31, 2027Estimated

First Submitted Date

Mar 28, 2025

First Submission Date that Met QC Criteria

Mar 28, 2025

First Posted Date

Apr 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remote ischemic conditioning plus Pneumatic Compression	Experimental		Device: Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb	Device	Arm Remote Ischemic Conditioning (4 cycles) plus Pneumatic Compression lower limb (100 mmHg for 1 hour)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of intervention completion	The primary outcome measure is the feasibility of intervention completion as assessed by proportion of patients able to complete the treatment protocol including pre-treatment assessment, intervention, and post-treatment assessment.	End of intervention at 1 hour

Secondary Outcomes

Measure	Description	Time Frame
Tolerability of intervention	The secondary outcome measure is tolerability of intervention as assessed by the 5-point Likert scale (1 Very comfortable, 2 Comfortable, 3 neither comfortable nor uncomfortable, 4 uncomfortable, 5 very uncomfortable).	End of intervention at 1 hour
Change in cortical oxygenation content

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Emmanuella Osuji, PMP, MSc	Contact	780-492-4137		osuji@ualberta.ca

Name	Affiliation	Role
Mahesh Kate, MD, DM	University of Alberta	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

6 months after completion of study

Access Criteria

Please contact the principal investigator

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided