REMOTE Ischemic Perconditioning Among Acute Ischemic Stroke Patients ( REMOTE-CAT)

NCT03375762 | Unknown DMC

• 1 other identifier: CEIC-1744
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 90±7

Secondary Outcomes (6)

• Early neurological improvement rate

  Day 1, day 5±1

• Treatment Related Serious Adverse Event Rates

  Day 1, day 5±1, day 90±7

• Size of the infarct volume

  Day 5±1

• Symptomatic intracranial hemorrhage

  24-36 hours

• Omic's response

  Day 1, day 3, day 5±1

Study Arms (2)

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.

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)

Other: Sham remote perconditioning

Interventions

Remote ischemic perconditioning OTHER

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

Usual care plus RIPerC

Sham remote perconditioning OTHER

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

Usual care plus Sham RIPerC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Biomedical Research Institute of Lleida (IRBLleida) Institut de Recerca Biomèdica de Lleida

Lleida, 25198, Spain

Location

Related Publications (7)

• 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.

  PMID: 24203849 BACKGROUND

• England 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.

  PMID: 28265014 BACKGROUND

• Heusch 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.

  PMID: 25593060 BACKGROUND

• Hess 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.

  PMID: 26585977 BACKGROUND

• Pan 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.

  PMID: 26812782 BACKGROUND

• Purroy 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.

  PMID: 40337071 DERIVED

• Purroy 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.

  PMID: 33101178 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor. PHD. MD. Principal investigator of Neuroclinical sciences group

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 18, 2017
• Study Start: August 7, 2019
• Primary Completion: March 15, 2024
• Study Completion: April 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

ES (1)