Ischemic StrokeREMOTE-CATNCT03375762
REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients ( REMOTE-CAT)
A study testing Remote ischemic perconditioning in people with Ischemic Stroke, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.
Trial summary
Stroke is one of the leading causes of death worldwide and the main cause of incapacity. Currently, the only therapies for acute ischemic stroke (AIS) patients are the administration of recombinant tissue plasminogen activator (rt-PA) and/or endovascular treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Remote ischemic perconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 572 participants
- Where
- 1 siteSpain
- Study dates
- 7 Aug 2019to 1 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old
- Suspected clinical stroke with 8 hours since onset of neurological symptoms
- Stroke code (SC) activation
- Independent in daily life before the onset of acute symptoms. (mrs</=2)
- Rapid arterial occlusion evaluation (RACE) scale score>0 and RACE motor item>0
- Written informed consent (patient or representative)
Who cannot join
- Unknown onset of symptoms
- Coma (GCS< 8)
- Malignancy or significant co-morbidity thought to limit life expectancy to <6 months
- Pregnancy
- Taking part in another interventional study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Biomedical Research Institute of Lleida (IRBLleida) Institut de Recerca Biomèdica de Lleida
Lleida, 25198
About this study
Official title: REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients in CATalonia: REMOTE-CAT PROJECT
Stroke is one of the leading causes of death worldwide and the main cause of incapacity. Currently, the only therapies for acute ischemic stroke (AIS) patients are the administration of recombinant tissue plasminogen activator (rt-PA) and/or endovascular treatment. Unfortunately, many patients cannot benefit from these therapies due to contraindications or evolution time. Neuroprotective therapies could not only increase the benefits of available reperfusion therapies but also provide an option for patients who are not candidates for these treatments. Remote ischemic conditioning, consisting on brief episodes of transient limb ischemia, represents a new paradigm in neuroprotection. It can be categorized in pre-, per- or postconditioning, depending on the moment of application. According to studies in coronary ischemia, remote ischemic perconditioning (RIPerC) during the ischemic event is safe, cost-effective, feasible and associated with a reduction in myocardial injury. The investigators aim to conduct a multicentre study (5 university hospitals) of pre-hospital RIPerC in AIS patients (within 8 hours of stroke onset), which would include 572 stroke code activated patients (286 would undergo RIPerC and 286 would be sham). Our hypothesis is that RIPerC would be safe and would induce endogenous neuroprotective phenomena associated with good outcomes in AIS patients whether treated with revascularization therapies or not. Moreover, the development of systemic ischemic tolerance should provide metabolomic and lipidomic signatures that would present an opportunity to find specific molecular markers (biomarkers). The main objectives will be to assess: 1) RIPerC clinical benefits in AIS, 2) whether RIPerC is safe not only in AIS but also in all cases of stroke code activation, 3) whether RIPerC is associated with a reduction in cerebral infarct size and 4) metabolomic and lipidomic signatures of the RIPerC effect.
Read the detailed description
Stroke is one of the leading causes of death worldwide and the main cause of incapacity. Currently, the only therapies for acute ischemic stroke (AIS) patients are the administration of rt-PA and/or endovascular treatment. Unfortunately, many patients cannot benefit from these therapies due to contraindications or evolution time. Neuroprotective therapies could not only increase the benefits of available reperfusion therapies but also provide an option for patients who are not candidates for these treatments. However, most neuroprotection trials have so far failed to demonstrate their efficacy in acute phase stroke patients, despite good results in animal studies. Remote ischemic perconditioning (RIPerC) represents a new paradigm in neuroprotection. It upregulates endogenous defense systems to achieve ischemic tolerance in brain ischemia. It consists of brief episodes of transient limb ischemia. According to studies in coronary ischemia, RIPerC during the ischemic event is safe, feasible and related to reduction in myocardial injury. However, there is only limited data about the clinical utility of RIC in AIS patients. Only one small single-centre, randomized, open label clinical trial has been conducted to test RIPerC in AIS patients as an adjunctive therapy intravenous alteplase in the prehospital setting.
The investigators want to conduct a multicenter study (involving 5 university hospitals) of prehospital RIPerC in AIS patients (within 8 hours of stroke onset) in which 572 stroke code activated patients will be included (286 subjects will undergo RIPerC and 286 subjects will be sham). RIPerC will consist of five cycles of electronic tourniquet inflation during five minutes and deflation during five minutes. The main endpoint will be a good clinical outcome measured by the modified Rankin score. The investigators will also establish a secondary neuroimaging endpoint defined by the infarct size observed in a Magnetic resonance imaging performed at three days. In addition, the investigators will conduct a substudy of biomarkers in 100 patients.
Our hypothesis is that RIPerC will be safe and will induce endogenous neuroprotective phenomenon responsible for good outcome in AIS patients whether treated with revascularization therapies or not. Moreover, the development of systemic ischemic tolerance will provide a metabolomic and lipidomic signature that will offer the opportunity to find specific molecular markers (biomarkers).
Project Objectives:
- To assess RIPerC clinical benefit in AIS measured by the modified Rankin Scale (mRS) score <3.
- To evaluate whether RIPerC is safe not only in AIS but also in all cases of stroke code activation.
- To assess whether RIPerC is associated with a reduction of cerebral infarct size.
- To identify the metabolomic and lipidomic signatures of the RIPerC effect.
- Conditions
- Ischemic Stroke
- Being tested
- Remote ischemic perconditioning, Sham remote perconditioning
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic perconditioningOther
Five 5-minute inflations/deflations of an automatic device placed on the upper non-paretic arm initiated in the ambulance on the way to hospital in the case of stroke code activation and RACE score >0 and RACE motor item>0
Sham remote perconditioningOther
Sham five 5-minute inflations/deflations of an automatic device placed on the upper non-paretic arm initiated in the ambulance on the way to hospital in the case of stroke code activation and RACE score >0 and RACE motor item>0
| Study group | Role | What they receive |
|---|---|---|
| Usual care plus RIPerC | Experimental | Usual care for stroke code patients, with or without revascularization therapies, with Remote ischemic perconditioning (RIPerC) using an electronic tourniquet. Receives: Other: Remote ischemic perconditioning |
| Usual care plus Sham RIPerC | Sham comparator | Usual care for stroke code patients, with or without revascularization therapies, with Sham remote ischemic conditioning (RIPerC) Receives: Other: Sham remote perconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependency
Modified Rankin Scale (MRS) <3. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels: 0 (no symptom) to 5 (severe disability) and 6 (death).
Measured: Day 90±7
Secondary outcomes (6)
Early neurological improvement rate
NIHSS decrease >=4 with respect to baseline
Measured: Day 1, day 5±1
Treatment Related Serious Adverse Event Rates
Number of participants with a serious adverse event related to treatment
Measured: Day 1, day 5±1, day 90±7
Size of the infarct volume
The infarct volume will be defined as the hyperintense area on the initial isotropic DWI acquired with a b value of 1000 sec/mm2
Measured: Day 5±1
Symptomatic intracranial hemorrhage
Symptomatic intracerebral hemorrhage (SICH) defined by the Safe Implementation of Thrombolysis in Stroke Monitoring Study protocol
Measured: 24-36 hours
Omic's response
Metabolomic and lipidomic analyses to define a panel of serum biomarkers accurately related to Remote ischemic conditioning phenomenon.
Measured: Day 1, day 3, day 5±1
Early dependency
Modified Rankin Scale <3. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels: 0 (no symptom) to 5 (severe disability) and 6 (death).
Measured: Day 5±1,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start7 Aug 2019
- Primary completion15 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Francisco Purroy, Institut de Recerca Biomèdica de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375762
- Sponsor's protocol ID
- CEIC-1744
- Acronym
- REMOTE-CAT
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.
PubMed 24203849England TJ, Hedstrom A, O'Sullivan S, Donnelly R, Barrett DA, Sarmad S, Sprigg N, Bath PM. RECAST (Remote Ischemic Conditioning After Stroke Trial): A Pilot Randomized Placebo Controlled Phase II Trial in Acute Ischemic Stroke. Stroke. 2017 May;48(5):1412-1415. doi: 10.1161/STROKEAHA.116.016429. Epub 2017 Mar 6.
PubMed 28265014Heusch G, Botker HE, Przyklenk K, Redington A, Yellon D. Remote ischemic conditioning. J Am Coll Cardiol. 2015 Jan 20;65(2):177-95. doi: 10.1016/j.jacc.2014.10.031.
PubMed 25593060Hess DC, Blauenfeldt RA, Andersen G, Hougaard KD, Hoda MN, Ding Y, Ji X. Remote ischaemic conditioning-a new paradigm of self-protection in the brain. Nat Rev Neurol. 2015 Dec;11(12):698-710. doi: 10.1038/nrneurol.2015.223. Epub 2015 Nov 20.
PubMed 26585977Pan J, Li X, Peng Y. Remote ischemic conditioning for acute ischemic stroke: dawn in the darkness. Rev Neurosci. 2016 Jul 1;27(5):501-10. doi: 10.1515/revneuro-2015-0043.
PubMed 26812782Purroy F, Arque G, Jimenez-Fabrega X, Subirats T, Ropero JR, Vicente-Pascual M, Cardona P, Gomez-Choco M, Pagola J, Abilleira S, Rovira A, Cirer-Sastre R, Mauri-Capdevila G; REMOTE-CAT Trial Investigators. Prehospital application of remote ischaemic perconditioning in acute ischaemic stroke patients in Catalonia: the REMOTE-CAT clinical trial. EClinicalMedicine. 2025 Apr 25;83:103208. doi: 10.1016/j.eclinm.2025.103208. eCollection 2025 May.
PubMed 40337071Purroy F, Arque G, Mauri G, Garcia-Vazquez C, Vicente-Pascual M, Pereira C, Vazquez-Justes D, Torres-Querol C, Vena A, Abilleira S, Cardona P, Forne C, Jimenez-Fabrega X, Pagola J, Portero-Otin M, Rodriguez-Campello A, Rovira A, Marti-Fabregas J. REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients in Catalonia: REMOTE-CAT PROJECT. Front Neurol. 2020 Sep 25;11:569696. doi: 10.3389/fneur.2020.569696. eCollection 2020.
PubMed 33101178
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients in CATalonia: REMOTE-CAT PROJECT
- ClinicalTrials.gov ID
- NCT03375762
- Acronym / sponsor ID
- REMOTE-CAT / CEIC-1744
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- Institut de Recerca Biomèdica de LleidaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 18 Dec 2017 (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.
Stroke is one of the leading causes of death worldwide and the main cause of incapacity. Currently, the only therapies for acute ischemic stroke (AIS) patients are the administration of recombinant tissue plasminogen activator (rt-PA) and/or endovascular treatment. Unfortunately, many patients cannot benefit from these therapies due to contraindications or evolution time. Neuroprotective therapies could not only increase the benefits of available reperfusion therapies but also provide an option for patients who are not candidates for these treatments. Remote ischemic conditioning, consisting on brief episodes of transient limb ischemia, represents a new paradigm in neuroprotection. It can be categorized in pre-, per- or postconditioning, depending on the moment of application. According to studies in coronary ischemia, remote ischemic perconditioning (RIPerC) during the ischemic event is safe, cost-effective, feasible and associated with a reduction in myocardial injury. The investigators aim to conduct a multicentre study (5 university hospitals) of pre-hospital RIPerC in AIS patients (within 8 hours of stroke onset), which would include 572 stroke code activated patients (286 would undergo RIPerC and 286 would be sham). Our hypothesis is that RIPerC would be safe and would induce endogenous neuroprotective phenomena associated with good outcomes in AIS patients whether treated with revascularization therapies or not. Moreover, the development of systemic ischemic tolerance should provide metabolomic and lipidomic signatures that would present an opportunity to find specific molecular markers (biomarkers). The main objectives will be to assess: 1) RIPerC clinical benefits in AIS, 2) whether RIPerC is safe not only in AIS but also in all cases of stroke code activation, 3) whether RIPerC is associated with a reduction in cerebral infarct size and 4) metabolomic and lipidomic signatures of the RIPerC effect.
Detailed description
Stroke is one of the leading causes of death worldwide and the main cause of incapacity. Currently, the only therapies for acute ischemic stroke (AIS) patients are the administration of rt-PA and/or endovascular treatment. Unfortunately, many patients cannot benefit from these therapies due to contraindications or evolution time. Neuroprotective therapies could not only increase the benefits of available reperfusion therapies but also provide an option for patients who are not candidates for these treatments. However, most neuroprotection trials have so far failed to demonstrate their efficacy in acute phase stroke patients, despite good results in animal studies. Remote ischemic perconditioning (RIPerC) represents a new paradigm in neuroprotection. It upregulates endogenous defense systems to achieve ischemic tolerance in brain ischemia. It consists of brief episodes of transient limb ischemia. According to studies in coronary ischemia, RIPerC during the ischemic event is safe, feasible and related to reduction in myocardial injury. However, there is only limited data about the clinical utility of RIC in AIS patients. Only one small single-centre, randomized, open label clinical trial has been conducted to test RIPerC in AIS patients as an adjunctive therapy intravenous alteplase in the prehospital setting.
The investigators want to conduct a multicenter study (involving 5 university hospitals) of prehospital RIPerC in AIS patients (within 8 hours of stroke onset) in which 572 stroke code activated patients will be included (286 subjects will undergo RIPerC and 286 subjects will be sham). RIPerC will consist of five cycles of electronic tourniquet inflation during five minutes and deflation during five minutes. The main endpoint will be a good clinical outcome measured by the modified Rankin score. The investigators will also establish a secondary neuroimaging endpoint defined by the infarct size observed in a Magnetic resonance imaging performed at three days. In addition, the investigators will conduct a substudy of biomarkers in 100 patients.
Our hypothesis is that RIPerC will be safe and will induce endogenous neuroprotective phenomenon responsible for good outcome in AIS patients whether treated with revascularization therapies or not. Moreover, the development of systemic ischemic tolerance will provide a metabolomic and lipidomic signature that will offer the opportunity to find specific molecular markers (biomarkers).
Project Objectives:
- To assess RIPerC clinical benefit in AIS measured by the modified Rankin Scale (mRS) score <3.
- To evaluate whether RIPerC is safe not only in AIS but also in all cases of stroke code activation.
- To assess whether RIPerC is associated with a reduction of cerebral infarct size.
- To identify the metabolomic and lipidomic signatures of the RIPerC effect.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care plus RIPerC | Experimental | Other: Remote ischemic perconditioningUsual care for stroke code patients, with or without revascularization therapies, with Remote ischemic perconditioning (RIPerC) using an electronic tourniquet. |
| Usual care plus Sham RIPerC | Sham comparator | Other: Sham remote perconditioningUsual care for stroke code patients, with or without revascularization therapies, with Sham remote ischemic conditioning (RIPerC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years old
- Suspected clinical stroke with 8 hours since onset of neurological symptoms
- Stroke code (SC) activation
- Independent in daily life before the onset of acute symptoms. (mrs</=2)
- Rapid arterial occlusion evaluation (RACE) scale score>0 and RACE motor item>0
Key exclusion criteria (5 listed)
- Unknown onset of symptoms
- Coma (GCS< 8)
- Malignancy or significant co-morbidity thought to limit life expectancy to <6 months
- Pregnancy
- Taking part in another interventional study
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 perconditioningFive 5-minute inflations/deflations of an automatic device placed on the upper non-paretic arm initiated in the ambulance on the way to hospital in the case of stroke code activation and RACE score >0 and RACE motor item>0 | Other | Usual care plus RIPerC |
| Sham remote perconditioningSham five 5-minute inflations/deflations of an automatic device placed on the upper non-paretic arm initiated in the ambulance on the way to hospital in the case of stroke code activation and RACE score >0 and RACE motor item>0 | Other | Usual care plus Sham RIPerC |
Primary outcome
Dependency
Time frame: Day 90±7
Modified Rankin Scale (MRS) <3. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels: 0 (no symptom) to 5 (severe disability) and 6 (death).
6 secondary outcomes
Early neurological improvement rate
Time frame: Day 1, day 5±1
Treatment Related Serious Adverse Event Rates
Time frame: Day 1, day 5±1, day 90±7
Size of the infarct volume
Time frame: Day 5±1
Symptomatic intracranial hemorrhage
Time frame: 24-36 hours
Omic's response
Time frame: Day 1, day 3, day 5±1
Early dependency
Time frame: Day 5±1,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 24203849Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.
- Background: PubMed 28265014England TJ, Hedstrom A, O'Sullivan S, Donnelly R, Barrett DA, Sarmad S, Sprigg N, Bath PM. RECAST (Remote Ischemic Conditioning After Stroke Trial): A Pilot Randomized Placebo Controlled Phase II Trial in Acute Ischemic Stroke. Stroke. 2017 May;48(5):1412-1415. doi: 10.1161/STROKEAHA.116.016429. Epub 2017 Mar 6.
- Background: PubMed 25593060Heusch G, Botker HE, Przyklenk K, Redington A, Yellon D. Remote ischemic conditioning. J Am Coll Cardiol. 2015 Jan 20;65(2):177-95. doi: 10.1016/j.jacc.2014.10.031.
- Background: PubMed 26585977Hess DC, Blauenfeldt RA, Andersen G, Hougaard KD, Hoda MN, Ding Y, Ji X. Remote ischaemic conditioning-a new paradigm of self-protection in the brain. Nat Rev Neurol. 2015 Dec;11(12):698-710. doi: 10.1038/nrneurol.2015.223. Epub 2015 Nov 20.
- Background: PubMed 26812782Pan J, Li X, Peng Y. Remote ischemic conditioning for acute ischemic stroke: dawn in the darkness. Rev Neurosci. 2016 Jul 1;27(5):501-10. doi: 10.1515/revneuro-2015-0043.
- Derived from this study: PubMed 40337071Purroy F, Arque G, Jimenez-Fabrega X, Subirats T, Ropero JR, Vicente-Pascual M, Cardona P, Gomez-Choco M, Pagola J, Abilleira S, Rovira A, Cirer-Sastre R, Mauri-Capdevila G; REMOTE-CAT Trial Investigators. Prehospital application of remote ischaemic perconditioning in acute ischaemic stroke patients in Catalonia: the REMOTE-CAT clinical trial. EClinicalMedicine. 2025 Apr 25;83:103208. doi: 10.1016/j.eclinm.2025.103208. eCollection 2025 May.
- Derived from this study: PubMed 33101178Purroy F, Arque G, Mauri G, Garcia-Vazquez C, Vicente-Pascual M, Pereira C, Vazquez-Justes D, Torres-Querol C, Vena A, Abilleira S, Cardona P, Forne C, Jimenez-Fabrega X, Pagola J, Portero-Otin M, Rodriguez-Campello A, Rovira A, Marti-Fabregas J. REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients in Catalonia: REMOTE-CAT PROJECT. Front Neurol. 2020 Sep 25;11:569696. doi: 10.3389/fneur.2020.569696. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 perconditioning in people with Ischemic Stroke, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Spain. 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?
Results are not available in the source record.
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?
Dependency (time frame: Day 90±7). 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 NCT03375762, which also lists 7 linked publications.
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 3 Jan 2024.