StrokePhase 2ReCAST-2NCT02779712
Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)
A Phase 2 study testing Remote ischaemic conditioning in people with Stroke, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Remote ischaemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Aug 2016to 23 Jul 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected clinical stroke with 6 hours of onset of neurological symptoms;
- Age >18;
- Written or witnessed oral consent, or relative/consultee advice.
Who cannot join
- Pre-morbid dependency mRS>3;
- Dementia;
- Coma (GCS< 8);
- Malignancy or significant co-morbidity thought to limit life expectancy to <6 months;
- Blood sugar < 3.5 mmol/L;
- Taking part in another clinical trial of an investigational medicinal product (CTIMP);
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Derby Teaching Hospitals Foundation Trust
Derby, Derbyshire, DE22 3DT
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2): A Pilot Randomised Controlled Phase II Trial Evaluating Remote Ischaemic Conditioning (RIC) After Hyperacute Stroke 2
Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be neuroprotective and help restore functional outcome when compared to control. These outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. The mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic conditioning (IC) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. The investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC. Secondary outcomes include tolerability, safety and clinical efficacy. The results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.
- Conditions
- Stroke
- Being tested
- Remote ischaemic conditioning, Sham
- Keywords
- Remote ischaemic conditioning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischaemic conditioningProcedure or surgery
1 dose (=4 cycles) of intermittent upper limb ischaemia (1 cycle = 5minutes inflation to 20mmHg above systolic BP, 5 minutes deflation). Dose escalation: (i) Recruits 1-20 receive this cycle once (ii) Recruits 21-40 receive a second dose of 4-cycles one hour after the first. (iii) Recruits 41-60 receive further dosing, twice daily until day 4.
ShamProcedure or surgery
4 cycles of intermittent sham procedure (1 cycle = 5 minutes inflation to 30 mmHg, 5 minutes deflation), matching the dose escalation described in the intervention
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischaemic Conditioning | Active comparator | Remote ischaemic conditioning (RIC group): 4 cycles of intermittent limb ischaemia - alternating 5 minutes inflation (20mmHg above systolic BP) followed by 5 minutes deflation of a standard upper arm blood pressure cuff Receives: Procedure: Remote ischaemic conditioning |
| Control | Sham comparator | Control: 4 cycles of alternating 5 minutes inflation (up to 30 mmHg) followed by 5 minutes deflation of a standard upper arm blood pressure cuff Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial feasibility
Recruitment feasibility (recruitment rate)
Measured: 90 days
Secondary outcomes (10)
Vascular Event Rate [Safety and Tolerability]
Number of participants with a vascular event (including limb ischaemia, recurrent stroke, myocardial infarction, venous thrombo-embolism)
Measured: Day 1, Day 4±1, day 90±7
Treatment Related Serious Adverse Event Rates [Safety and Tolerability]
Number of participants with a serious adverse event related to treatment
Measured: Day 1, Day 4±1, day 90±7
Biomarkers
Plasma S100-beta protein
Measured: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Biomarkers
Plasma heat-shock proteins
Measured: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Biomarkers
Plasma cytokines
Measured: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Impairment
National Institutes of Health Stroke Scale
Measured: Day 4±1, day 90±7
Dependency
Modified Rankin scale
Measured: Day 90±7
Disability
Barthel Index
Measured: Day 90±7
Mood
Zung depression scale
Measured: Day 90±7
Telephone cognition
Modified Telephone Interview for Cognitive Status (TICS-M)
Measured: Day 90±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start1 Aug 2016
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779712
- Sponsor's protocol ID
- 16007
- Acronym
- ReCAST-2
- Status last verified
- Jul 2017
- First submitted
- 22 Jan 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
England TJ, Hedstrom A, O'Sullivan SE, Woodhouse L, Jackson B, Sprigg N, Bath PM. Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke. J Am Heart Assoc. 2019 Dec 3;8(23):e013572. doi: 10.1161/JAHA.119.013572. Epub 2019 Nov 21.
PubMed 31747864
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2): A Pilot Randomised Controlled Phase II Trial Evaluating Remote Ischaemic Conditioning (RIC) After Hyperacute Stroke 2
- ClinicalTrials.gov ID
- NCT02779712
- Acronym / sponsor ID
- ReCAST-2 / 16007
- Conditions
- Stroke
- Keywords
- Remote ischaemic conditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 20 May 2016 (estimated)
- 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.
Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be neuroprotective and help restore functional outcome when compared to control. These outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. The mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic conditioning (IC) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. The investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC. Secondary outcomes include tolerability, safety and clinical efficacy. The results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischaemic Conditioning | Active comparator | Procedure: Remote ischaemic conditioningRemote ischaemic conditioning (RIC group): 4 cycles of intermittent limb ischaemia - alternating 5 minutes inflation (20mmHg above systolic BP) followed by 5 minutes deflation of a standard upper arm blood pressure cuff |
| Control | Sham comparator | Procedure: ShamControl: 4 cycles of alternating 5 minutes inflation (up to 30 mmHg) followed by 5 minutes deflation of a standard upper arm blood pressure cuff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suspected clinical stroke with 6 hours of onset of neurological symptoms;
- Age >18;
- Written or witnessed oral consent, or relative/consultee advice.
Key exclusion criteria (7 listed)
- Pre-morbid dependency mRS>3;
- Dementia;
- Coma (GCS< 8);
- Malignancy or significant co-morbidity thought to limit life expectancy to <6 months;
- Blood sugar < 3.5 mmol/L;
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 ischaemic conditioning1 dose (=4 cycles) of intermittent upper limb ischaemia (1 cycle = 5minutes inflation to 20mmHg above systolic BP, 5 minutes deflation). Dose escalation: (i) Recruits 1-20 receive this cycle once (ii) Recruits 21-40 receive a second dose of 4-cycles one hour after the first. (iii) Recruits 41-60 receive further dosing, twice daily until day 4. | Procedure or surgery | Remote Ischaemic Conditioning |
| Sham4 cycles of intermittent sham procedure (1 cycle = 5 minutes inflation to 30 mmHg, 5 minutes deflation), matching the dose escalation described in the intervention | Procedure or surgery | Control |
Primary outcome
Trial feasibility
Time frame: 90 days
Recruitment feasibility (recruitment rate)
10 secondary outcomes
Vascular Event Rate [Safety and Tolerability]
Time frame: Day 1, Day 4±1, day 90±7
Treatment Related Serious Adverse Event Rates [Safety and Tolerability]
Time frame: Day 1, Day 4±1, day 90±7
Biomarkers
Time frame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Biomarkers
Time frame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Biomarkers
Time frame: Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1
Impairment
Time frame: Day 4±1, day 90±7
Dependency
Time frame: Day 90±7
Disability
Time frame: Day 90±7
Mood
Time frame: Day 90±7
Telephone cognition
Time frame: Day 90±7
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 11 Oct 2018.
- Derived from this study: PubMed 31747864England TJ, Hedstrom A, O'Sullivan SE, Woodhouse L, Jackson B, Sprigg N, Bath PM. Remote Ischemic Conditioning After Stroke Trial 2: A Phase IIb Randomized Controlled Trial in Hyperacute Stroke. J Am Heart Assoc. 2019 Dec 3;8(23):e013572. doi: 10.1161/JAHA.119.013572. Epub 2019 Nov 21.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
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Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remote ischaemic conditioning in people with Stroke, run by University of Nottingham at 2 sites in United Kingdom.
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 3 inclusion and 7 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Trial feasibility (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779712, which also lists 1 linked publication.
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 11 Oct 2018.