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

December 30, 2023 updated by: Francisco Purroy, Institut de Recerca Biomèdica de Lleida

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

572

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • Biomedical Research Institute of Lleida (IRBLleida) Institut de Recerca Biomèdica de Lleida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usual care plus RIPerC
Usual care for stroke code patients, with or without revascularization therapies, with Remote ischemic perconditioning (RIPerC) using an electronic tourniquet.
Other: Remote ischemic perconditioning
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 Comparator: Usual care plus Sham RIPerC
Usual care for stroke code patients, with or without revascularization therapies, with Sham remote ischemic conditioning (RIPerC)
Other: Sham remote perconditioning
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 90±7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early neurological improvement rate
Time Frame: Day 1, day 5±1
NIHSS decrease >=4 with respect to baseline
Day 1, day 5±1
Treatment Related Serious Adverse Event Rates
Time Frame: Day 1, day 5±1, day 90±7
Number of participants with a serious adverse event related to treatment
Day 1, day 5±1, day 90±7
Size of the infarct volume
Time Frame: Day 5±1
The infarct volume will be defined as the hyperintense area on the initial isotropic DWI acquired with a b value of 1000 sec/mm2
Day 5±1
Symptomatic intracranial hemorrhage
Time Frame: 24-36 hours
Symptomatic intracerebral hemorrhage (SICH) defined by the Safe Implementation of Thrombolysis in Stroke Monitoring Study protocol
24-36 hours
Omic's response
Time Frame: Day 1, day 3, day 5±1
Metabolomic and lipidomic analyses to define a panel of serum biomarkers accurately related to Remote ischemic conditioning phenomenon.
Day 1, day 3, day 5±1
Early dependency
Time Frame: Day 5±1,
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).
Day 5±1,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recerca Biomèdica de Lleida

Collaborators

Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2019

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 30, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC-1744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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