Stroke, AcuteENOSNCT04266639
Rheo-Erythrocrine Dysfunction as a Biomarker for RIC Treatment in Acute Ischemic Stroke
A study testing Remote Ischemic Conditioning in people with Stroke, Acute and Ischemic Stroke, run by Grethe Andersen at 1 site in Denmark.
Trial summary
This study aims to investigate whether Remote Ischemic Conditioning (RIC) improves rheo-erythrocrine dysfunction in acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute, Ischemic Stroke, Cerebrovascular Disorders
- What is being tested?
- Remote Ischemic Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Jul 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Onset to randomization < 48 hours
- Independent in daily living (mRS 0-2)
- Legal competent
- Ambulatory
- Documented ischemic stroke on baseline MRI
- Independent in daily living (mRS 0-2) Ambulatory
- Legal competent
- Non vascular diagnosis (e.g. epilepsy, migraine etc.)
Who cannot join
- Prior stroke, dementia or other known neurological condition Pregnancy
- Contraindications to MRI
- Investigators discretion
- Known upper extremity peripheral arterial stenosis Diabetes
- CONTROLS
- Prior stroke, dementia or other known neurological condition
Show all 10Show fewer
- Pregnancy
- Contraindications to MRI
- Investigators discretion
- Known upper extremity peripheral arterial stenosis Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rheo-Erythrocrine Dysfunction as a Biomarker for RIC Treatment in Acute Ischemic Stroke - Pilot, Single-center, Randomized, Patient-assessor Blinded, Sham-controlled Study
This study aims to investigate whether Remote Ischemic Conditioning (RIC) improves rheo-erythrocrine dysfunction in acute ischemic stroke
Read the detailed description
Stroke is a leading cause of death and disability worldwide. Of all strokes, 85% are ischemic strokes caused by a thrombus or an embolus. The additional 15% are caused by hemorrhage. Currently the only approved treatments for ischemic strokes are thrombolysis given within 4.5 hours and thrombectomy performed within 6 hours of symptom onset - in some cases up to 24 hours. The majority of stroke patients are not however eligible for acute reperfusion therapy, mainly due to time constrains and late presentation. Novel neuroprotective strategies available for all stroke patients are thus urgently needed.
Remote Ischemic Conditioning (RIC) is a simple intervention in which transient ischemia is induced in an extremity by repetitive inflation-deflation of a blood pressure cuff. It remains uncertain exactly how the protective effect of RIC is transmitted and communicated between the extremity and the brain. Both humoral, immunological and neuronal pathways seem to be involved. Treatment with RIC and has proven to be a safe, feasible and low-cost treatment in clinical settings.
Biomarkers of the RIC treatment is a new area of stroke research and are important to establish in order to assess and predict responders of the conditioning treatment. Rheo-erythrocrine dysfunction of the Red Blood Cell (RBC) is a novel biomarker in both ischemic strokes in general and on the effect of RIC. Red Blood Cells with a diameter of 6-8 μm must be highly deformable in order to deliver oxygen to brain tissue by travelling through micro vessels with a diameter of just 2-3 μm. RBC's can carry nitric oxide as NO2-/s-nitrosylated proteins. These proteins improve RBC deformability and induce hypoxic vasodilation thereby improving passage through the microvasculature. RBC's also express Erythrocyte Nitric Oxide Synthase 3, which regulate the rheo-erythrocrine function. Erythrocyte Nitric Oxide Synthase 3 is activated by shear stress and provide an extra source of NO for hypoxic vasodilation. Preliminary data have shown that experimental stroke on mice seems to cause a rheo-erythrocrine dysfunction of the RBC's leading to a loss of deformability. The RBC's become rigid, which can lead to occlusion of micro vessels in the brain and further ischemic damage. Loss of deformability can be measured as a reduced Elongation Index (EI) by ektacytometry and may be attenuated by RIC.
- Conditions
- Stroke, Acute, Ischemic Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
- Being tested
- Remote Ischemic Conditioning, Sham Remote Ischemic Conditioning
- Keywords
- Remote Ischemic Conditioning, Neuroprotection
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic ConditioningDevice
RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion
Sham Remote Ischemic ConditioningDevice
Sham Comparator (Sham-RIC)
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning | Active comparator | Remote Ischemic Conditioning (RIC) is applied during the in-hospital phase using an automated RIC device.
Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes of cuff deflation. The cuff pressure will be 200 mmHg; if initial systolic blood pressure is above 175 mmHg, the cuff is automatically inflated to 35 mmHg above the systolic blood pressure.
* Initial Remote Ischemic Conditioning: < 2 hours from inclusion
* Remote Ischemic Postconditioning: twice daily for 7 days
Usual care with or without acute reperfusion therapy Receives: Device: Remote Ischemic Conditioning |
| Sham - Remote Ischemic Conditioning | Sham comparator | Sham Remote Ischemic Conditioning (Sham-RIC) is applied during the in-hospital phase using an automated Sham-RIC device.
Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes of cuff deflation. The cuff pressure will be always be 20 mmHg.
* Initial Sham Remote Ischemic Conditioning: < 2 hours from inclusion
* Sham Remote ischemic Postconditioning: twice daily for 7 days
Usual care with or without acute reperfusion therapy. Receives: Device: Sham Remote Ischemic Conditioning |
| Controls | No intervention | The control group will not receive treatment with Remote Ischemic Conditioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC deformability will serve as a biomarker of the conditioning response and predictor of the clinical outcome in stroke patients.
RBC deformability is measured as Deformability or Elongation Index (DI or EI, Rheoscan AnD-300, RheoMeditech, South Chorea). A higher EI at the optimum viscosity (300 Osmolality) indicates highly deformable RBCs indicative of better microcirculation, while a lower EI indicates rigid RBC's. Briefly, 6 µL of heparinized or EDTA treated fresh blood is mixed with 600-µL of polyvinylpyrrolidone (PVP) solution (300 Osm) and transferred to a disposable kit. The kit is placed inside the laser-assisted ectacytometer for automated read out, data and image collection as per the vendor's instructions.
Measured: 1 week
RBC deformability will serve as a biomarker of the conditioning response and predictor of the clinical outcome in stroke patients
For measurement of shear stress, 0,5 mL of heparinized or EDTA treated fresh blood is mixed with 600-µL of polyvinylpyrrolidone (PVP) solution (300 Osm) and transferred to a disposable kit. The kit is placed inside the laser-assisted ectacytometer for automated read out, data and image collection as per the vendor's instructions.
Measured: 1 week
Secondary outcomes (14)
Nitric oxide quantification using DAF-FM-Diacetate flowcytometry as a biomarker of the conditioning response
Analytical flowcytometry with DAF-FM-Diacetate (4-Amino-5-Methylamino-2',7'-Difluorofluorescein Diacetate) on wholeblood samples
Measured: 1 week
Nitric oxide quantification using DAF-FM-Diacetate flowcytometry as a predictor of the short term clinical outcome in stroke patients
Analytical flowcytometry with DAF-FM-Diacetate (4-Amino-5-Methylamino-2',7'-Difluorofluorescein Diacetate) on wholeblood samples
Measured: 1 week
RBC deformability presentation across stroke subtypes
Ektacytometry (see primary outcome)
Measured: 1 week
RBC deformability in relation to infarct size/stroke severity
Ektacytometry (see primary outcome)
Measured: 1 week
RBC erythrocrine dysfunction (NOS3) presentation across stroke subtypes
Comparison of RBC Nitric Oxide Synthestase 3 activation (flowcytometry) across stroke subtypes.
Measured: 9 months
RBC erythrocrine dysfunction (nitric oxide) presentation across stroke subtypes
Comparison of nitric oxide estimation (chemiluminescence) across stroke subtypes
Measured: 9 months
RBC erythrocrine dysfunction (NOS3) in relation to infarct size/stroke severity
Level of RBC Nitric Oxide Synthestase 3 activation (flowcytometry)
Measured: 9 months
RBC erythrocrine dysfunction (nitric) in relation to infarct size/stroke severity
Level of nitric oxide estimation (chemiluminescence)
Measured: 9 months
Difference in 7 days cognitive impairment between treatment groups
Difference between baseline Montreal Cognitive Assessment (MoCA) score and day 7 MoCA score.
MoCA is a 1-page (healthcare administered), 0-30-point test (30 is the best score), administrable in ≈10 minutes. The test evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space.
Measured: 1 week
RBC erythrocrine dysfunction and deformability as a marker for difference in 7 days cognitive impairment (MoCA scale)
Cognitive impairment is measured using the Montreal Cognitive Assessment scale (MoCA), which is a 1-page (healthcare administered), 0-30-point test (30 is the best score), administrable in ≈10 minutes. The test evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space
Measured: 9 months
Circulating microRNA profile of RIC-induced neuroprotection
MicroRNAs will be identified with Illumina next-generation sequencing using the TruSeq Small RNA Sample Preparation kit. The output will be miRNA expression levels for each sample, which will form the basis for a miRNA differential analysis where miRNAs with statistically significant expression changes will be found
Measured: 9 months
Extracellular vesicle profile of RIC-induced neuroprotection
Extracellular vesicles (EVs, also known as exosomes) will be isolated from plasma samples before characterization of surface markers and content. Protein characterization will be done using ELISA and Western blots in addition to array techniques. To broaden the feasibility of finding stroke type specific EV surface markers, we will utilize recombinant antibody library techniques to find novel disease binders with the potential of diagnosing stroke types in blood samples. Nucleic acid (DNA and RNA including miRNA) content of EVs will be analyzed using next generation sequencing (NGS) and qRT-PCR
Measured: 9 months
Circulating microRNA as a marker for difference in 7 days cognitive impairment (MoCA score)
Cognitive impairment is measured using the Montreal Cognitive Assessment scale (MoCA), which is a 1-page (healthcare administered), 0-30-point test (30 is the best score), administrable in ≈10 minutes. The test evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space
Measured: 9 months
Extracellular vesicle profile as a marker for RBC erythrocrine dysfunction and deformability
Extracellular vesicles (EVs, also known as exosomes) will be isolated from plasma samples before characterization of surface markers and content. To broaden the feasibility of finding stroke type specific EV surface markers, we will utilize recombinant antibody library techniques to find novel disease binders with the potential of diagnosing stroke types in blood samples.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start29 Jul 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, Single-center, Randomized, Patient-assessor blinded, Sham-controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grethe Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grethe Andersen, Aarhus University Hospital
- Investigators
- Grethe Andersen, MD, DMSc, Principal investigator, Aarhus University Hospital, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266639
- Sponsor's protocol ID
- ENOS
- Acronym
- ENOS
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheo-Erythrocrine Dysfunction as a Biomarker for RIC Treatment in Acute Ischemic Stroke - Pilot, Single-center, Randomized, Patient-assessor Blinded, Sham-controlled Study
- ClinicalTrials.gov ID
- NCT04266639
- Acronym / sponsor ID
- ENOS / ENOS
- Conditions
- Stroke, Acute, Ischemic Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
- Keywords
- Remote Ischemic Conditioning, Neuroprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Grethe AndersenUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether Remote Ischemic Conditioning (RIC) improves rheo-erythrocrine dysfunction in acute ischemic stroke
Detailed description
Stroke is a leading cause of death and disability worldwide. Of all strokes, 85% are ischemic strokes caused by a thrombus or an embolus. The additional 15% are caused by hemorrhage. Currently the only approved treatments for ischemic strokes are thrombolysis given within 4.5 hours and thrombectomy performed within 6 hours of symptom onset - in some cases up to 24 hours. The majority of stroke patients are not however eligible for acute reperfusion therapy, mainly due to time constrains and late presentation. Novel neuroprotective strategies available for all stroke patients are thus urgently needed.
Remote Ischemic Conditioning (RIC) is a simple intervention in which transient ischemia is induced in an extremity by repetitive inflation-deflation of a blood pressure cuff. It remains uncertain exactly how the protective effect of RIC is transmitted and communicated between the extremity and the brain. Both humoral, immunological and neuronal pathways seem to be involved. Treatment with RIC and has proven to be a safe, feasible and low-cost treatment in clinical settings.
Biomarkers of the RIC treatment is a new area of stroke research and are important to establish in order to assess and predict responders of the conditioning treatment. Rheo-erythrocrine dysfunction of the Red Blood Cell (RBC) is a novel biomarker in both ischemic strokes in general and on the effect of RIC. Red Blood Cells with a diameter of 6-8 μm must be highly deformable in order to deliver oxygen to brain tissue by travelling through micro vessels with a diameter of just 2-3 μm. RBC's can carry nitric oxide as NO2-/s-nitrosylated proteins. These proteins improve RBC deformability and induce hypoxic vasodilation thereby improving passage through the microvasculature. RBC's also express Erythrocyte Nitric Oxide Synthase 3, which regulate the rheo-erythrocrine function. Erythrocyte Nitric Oxide Synthase 3 is activated by shear stress and provide an extra source of NO for hypoxic vasodilation. Preliminary data have shown that experimental stroke on mice seems to cause a rheo-erythrocrine dysfunction of the RBC's leading to a loss of deformability. The RBC's become rigid, which can lead to occlusion of micro vessels in the brain and further ischemic damage. Loss of deformability can be measured as a reduced Elongation Index (EI) by ektacytometry and may be attenuated by RIC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Pilot, Single-center, Randomized, Patient-assessor blinded, Sham-controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning | Active comparator | Device: Remote Ischemic ConditioningRemote Ischemic Conditioning (RIC) is applied during the in-hospital phase using an automated RIC device. Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes of cuff deflation. The cuff pressure will be 200 mmHg; if initial systolic blood pressure is above 175 mmHg, the cuff is automatically inflated to 35 mmHg above the systolic blood pressure. * Initial Remote Ischemic Conditioning: < 2 hours from inclusion * Remote Ischemic Postconditioning: twice daily for 7 days Usual care with or without acute reperfusion therapy |
| Sham - Remote Ischemic Conditioning | Sham comparator | Device: Sham Remote Ischemic ConditioningSham Remote Ischemic Conditioning (Sham-RIC) is applied during the in-hospital phase using an automated Sham-RIC device. Treatment characteristics: Five cycles (50 minutes), each consisting of five minutes of cuff inflation followed by five minutes of cuff deflation. The cuff pressure will be always be 20 mmHg. * Initial Sham Remote Ischemic Conditioning: < 2 hours from inclusion * Sham Remote ischemic Postconditioning: twice daily for 7 days Usual care with or without acute reperfusion therapy. |
| Controls | No intervention | –The control group will not receive treatment with Remote Ischemic Conditioning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Onset to randomization < 48 hours
- Independent in daily living (mRS 0-2)
- Legal competent
- Ambulatory
- Documented ischemic stroke on baseline MRI
Key exclusion criteria (10 listed)
- Prior stroke, dementia or other known neurological condition Pregnancy
- Contraindications to MRI
- Investigators discretion
- Known upper extremity peripheral arterial stenosis Diabetes
- CONTROLS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic ConditioningRIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion | Device | Remote Ischemic Conditioning |
| Sham Remote Ischemic ConditioningSham Comparator (Sham-RIC) | Device | Sham - Remote Ischemic Conditioning |
Primary outcome
RBC deformability will serve as a biomarker of the conditioning response and predictor of the clinical outcome in stroke patients.
Time frame: 1 week
RBC deformability is measured as Deformability or Elongation Index (DI or EI, Rheoscan AnD-300, RheoMeditech, South Chorea). A higher EI at the optimum viscosity (300 Osmolality) indicates highly deformable RBCs indicative of better microcirculation, while a lower EI indicates rigid RBC's. Briefly, 6 µL of heparinized or EDTA treated fresh blood is mixed with 600-µL of polyvinylpyrrolidone (PVP) solution (300 Osm) and transferred to a disposable kit. The kit is placed inside the laser-assisted ectacytometer for automated read out, data and image collection as per the vendor's instructions.
RBC deformability will serve as a biomarker of the conditioning response and predictor of the clinical outcome in stroke patients
Time frame: 1 week
For measurement of shear stress, 0,5 mL of heparinized or EDTA treated fresh blood is mixed with 600-µL of polyvinylpyrrolidone (PVP) solution (300 Osm) and transferred to a disposable kit. The kit is placed inside the laser-assisted ectacytometer for automated read out, data and image collection as per the vendor's instructions.
14 secondary outcomes
Nitric oxide quantification using DAF-FM-Diacetate flowcytometry as a biomarker of the conditioning response
Time frame: 1 week
Nitric oxide quantification using DAF-FM-Diacetate flowcytometry as a predictor of the short term clinical outcome in stroke patients
Time frame: 1 week
RBC deformability presentation across stroke subtypes
Time frame: 1 week
RBC deformability in relation to infarct size/stroke severity
Time frame: 1 week
RBC erythrocrine dysfunction (NOS3) presentation across stroke subtypes
Time frame: 9 months
RBC erythrocrine dysfunction (nitric oxide) presentation across stroke subtypes
Time frame: 9 months
RBC erythrocrine dysfunction (NOS3) in relation to infarct size/stroke severity
Time frame: 9 months
RBC erythrocrine dysfunction (nitric) in relation to infarct size/stroke severity
Time frame: 9 months
Difference in 7 days cognitive impairment between treatment groups
Time frame: 1 week
RBC erythrocrine dysfunction and deformability as a marker for difference in 7 days cognitive impairment (MoCA scale)
Time frame: 9 months
Circulating microRNA profile of RIC-induced neuroprotection
Time frame: 9 months
Extracellular vesicle profile of RIC-induced neuroprotection
Time frame: 9 months
Circulating microRNA as a marker for difference in 7 days cognitive impairment (MoCA score)
Time frame: 9 months
Extracellular vesicle profile as a marker for RBC erythrocrine dysfunction and deformability
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grethe Andersen, MD, DMSc principal investigator
Aarhus University Hospital, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning in people with Stroke, Acute and Ischemic Stroke, run by Grethe Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC deformability will serve as a biomarker of the conditioning response and predictor of the clinical outcome in stroke patients. (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.