NCT05408130Completed
Remote Ischemic Conditioning With Novel Optical Sensor Feedback Device in Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 28 Aug 2024
Brief summary (registry, in English)
Stroke is a leading cause of physical and cognitive disabilities. The most common type of stroke is ischemic (lack of blood flow to the brain due to clot blocking a blood vessel). Many people with stroke (PwS) have changes on the brain imaging called small vessel disease (SVD). This is a condition that affects tiny blood vessels supplying the brain, leading to decreased blood flow in some parts of the brain. These brain changes may hamper the recovery process after stroke, or lead to recurrent stroke and cognitive impairment. SVD is a slow process that can be seen as multiple black spots on computed tomography or white spots on magnetic resonance imaging. Current treatments to reduce the effect of SVD on PwS are to control high blood pressure, high blood sugar, high cholesterol and increase physical activity. However, these approaches do not lead to a reduction in SVD. Remote Ischemic Conditioning is a type of treatment delivered with 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. Recent animal and human studies have suggested that the use of RIC may reduce the SVD load. A new device will be used to deliver remote ischemic conditioning therapy in a better manner. Existing devices generate the same amount of compression for all people. The pressure applied by the machine in the arm may be either more than required or less than required. The ideal compression would be one that achieves a low blood flow state in the arm at the least possible pressure. To achieve this our group is using a small light sensor to inform us. The light sensor is closely applied to the skin over the arm below the blood pressure cuff. It emits light that is absorbed by the skin and the light is then reflected. This is detected by other sensors placed together. From the reflected light the sensor can obtain information about blood flow in the skin. When the pressure increases with help of an automated machine the light sensor can detect that blood flow are reduced and this information is displayed on the computer. The information about skin blood flow will inform about the level of pressure to apply to give accurate treatment. The new device with optical feedback will deliver RIC in PwS and SVD in a safe and reliable manner. A total of 51 patients will take part in this study. Thirty-four will get remote ischemic conditioning therapy and 17 patients will get sham-control therapy. All patients will get standard post-stroke treatment according to the Canadian Stroke Best Practices Recommendation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 25 May 2022
- Start date
- 7 Jul 2022
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- University of Alberta
- Diseases
- Stroke
- NCT number
- NCT05408130
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 7 Jul 2022 to the primary completion date, 1 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Injury to the upper arm or any other musculoskeletal disability/pain precluding from tolerating RIC therapy
Other illness
- Treatment of ongoing malignancy with expected survival \< 6 months
- Presence of ongoing systemic infection with antibiotic therapy
- History of dermatological conditions affecting application of tissue perfusion sensor and remote ischemic conditioning pressure cuff
Other
- Patient is part of other clinical trial delivering intervention
- Presence of hypertensive urgency and emergency
- Presence of hemodynamic instability
- Pregnant and lactating women
Who the study is looking for
- Adult patients with ischemic stroke (anterior and posterior circulation involvement) with or without neurological deficit within 48h of symptom onset
- CT head or MRI Brain evidence of infarct
- CT head or MRI Brain evidence of moderate or severe small vessel disease. We will assess atrophy, leukoaraiosis and old vascular lesions.
- Premorbid functional disability assessed by mRS \<2
- National institute of Health Stroke scale \<15 at the time of enrollment
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
Related publications
- Monitoring of Remote Ischemic Conditioning with a Tissue Reflectance Sensor: A Randomized Control Trial.Cerebrovasc Dis · 2026 · PMID 42858287
This page is information, not medical advice. Discuss any trial with your doctor.