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NCT03375762: REMOTE-CAT

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

Status unknown NA Last updated 3 January 2024
What this trial tests

NA trial testing Remote ischemic perconditioning in Ischemic Stroke in 572 participants. Status unknown.

Timeline
7 August 2019
Primary endpoint
15 March 2024
1 April 2024

Quick facts

Lead sponsorInstitut de Recerca Biomèdica de Lleida
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposehealth services research
Enrollment572
Start date7 August 2019
Primary completion15 March 2024
Estimated completion1 April 2024
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Institut de Recerca Biomèdica de Lleida

Who can join

18 and older, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emerging neuroprotective strategies for the treatment of ischemic stroke: An overview of clinical and preclinical studies.
    Paul S, Candelario-Jalil E. · · 2021 · cited 531× · PMID 33144066 · DOI 10.1016/j.expneurol.2020.113518
  2. Effect of In-Hospital Remote Ischemic Perconditioning on Brain Infarction Growth and Clinical Outcomes in Patients With Acute Ischemic Stroke: The RESCUE BRAIN Randomized Clinical Trial.
    Pico F, Lapergue B, Ferrigno M, Rosso C, et al · · 2020 · cited 75× · PMID 32227157 · DOI 10.1001/jamaneurol.2020.0326
  3. Neuroprotection in Acute Ischemic Stroke: A Battle Against the Biology of Nature.
    Ghozy S, Reda A, Varney J, Elhawary AS, et al · · 2022 · cited 51× · PMID 35711268 · DOI 10.3389/fneur.2022.870141
  4. Remote ischemic conditioning for stroke: clinical data, challenges, and future directions.
    Zhao W, Li S, Ren C, Meng R, et al · · 2019 · cited 45× · PMID 30656197 · DOI 10.1002/acn3.691
  5. Remote but not Distant: a Review on Experimental Models and Clinical Trials in Remote Ischemic Conditioning as Potential Therapy in Ischemic Stroke.
    Mollet I, Marto JP, Mendonça M, Baptista MV, et al · · 2022 · cited 25× · PMID 34686988 · DOI 10.1007/s12035-021-02585-6
  6. Remote Ischemic Conditioning May Improve Disability and Cognition After Acute Ischemic Stroke: A Pilot Randomized Clinical Trial.
    Poalelungi A, Tulbă D, Turiac E, Stoian D, et al · · 2021 · cited 21× · PMID 34526950 · DOI 10.3389/fneur.2021.663400
  7. Induced neuroprotection by remote ischemic perconditioning as a new paradigm in ischemic stroke at the acute phase, a systematic review.
    Purroy F, García C, Mauri G, Pereira C, et al · · 2020 · cited 19× · PMID 32615939 · DOI 10.1186/s12883-020-01836-8
  8. Remote ischaemic conditioning for stroke: unanswered questions and future directions.
    Baig S, Moyle B, Nair KPS, Redgrave J, et al · · 2021 · cited 15× · PMID 33903181 · DOI 10.1136/svn-2020-000722

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Other recruiting trials for Ischemic Stroke

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