A multicentre, randomised, sham-controlled trial on REmote iSchemic conditioning In patients with acute STroke (RESIST) – Rationale and study design

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A multicentre, randomised, sham-controlled trial on REmote iSchemic conditioning In patients with acute STroke (RESIST) – Rationale and study design. / Blauenfeldt, Rolf A.; Hjort, Niels; Gude, Martin F.; Behrndtz, Anne B.; Fisher, Marc; Valentin, Jan B.; Kirkegaard, Hans; Johnsen, Søren P.; Hess, David C.; Andersen, Grethe.

I: European Stroke Journal, Bind 5, Nr. 1, 2020, s. 94-101.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

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@article{e25f01980c2244d1b5437caa24aa7c39,
title = "A multicentre, randomised, sham-controlled trial on REmote iSchemic conditioning In patients with acute STroke (RESIST) – Rationale and study design",
abstract = "Rationale: Remote ischaemic conditioning, applied in the prehospital setting and continued in-hospital, may improve functional outcome in patients with acute ischaemic stroke and intracerebral haemorrhage. Aims: To evaluate whether combined remote ischaemic per- and postconditioning can improve long-term functional outcome in acute ischaemic stroke and intracerebral haemorrhage patients. Methods and design: Danish multicentre, prospective, randomised, patient-assessor blinded, sham-controlled study. Adult patients with a putative stroke identified prehospital with symptom duration <4 h, who are independent in daily activities will be randomised 1:1 to remote ischaemic conditioning or Sham-remote ischaemic conditioning. The treatment protocol will be five cycles, each consisting of 5 min with a blood pressure cuff inflation and 5 min with a deflated cuff placed on the upper extremity. The cuff pressure for remote ischaemic conditioning will be 200 mmHg–285 mmHg according to the individual systolic blood pressure and 20 mmHg sham-remote ischaemic conditioning during inflation. The study is approved as an acute study and consent is waived in the acute phase. Sample size estimation: For a 7% increased odds for a beneficial shift on the modified Rankin Scale at a significance level of 5% and power of 90%, 1000 patients with a target diagnosis of acute ischaemic stroke and intracerebral haemorrhage and a total of 1500 patients with a prehospital presumed stroke will be included. Study outcomes: The primary outcome will be the modified Rankin Scale score measured at three-month follow-up (analysed using ordinal logistic regression). ClinicalTrials.gov Identifier: NCT03481777.",
keywords = "Acute ischaemic stroke, intracerebral haemorrhage, neuroprotection, perconditioning, postconditioning, prehospital, remote ischaemic conditioning",
author = "Blauenfeldt, {Rolf A.} and Niels Hjort and Gude, {Martin F.} and Behrndtz, {Anne B.} and Marc Fisher and Valentin, {Jan B.} and Hans Kirkegaard and Johnsen, {S{\o}ren P.} and Hess, {David C.} and Grethe Andersen",
year = "2020",
doi = "10.1177/2396987319884408",
language = "English",
volume = "5",
pages = "94--101",
journal = "European Stroke Journal",
issn = "2396-9873",
publisher = "SAGE Publications",
number = "1",

}

RIS

TY - JOUR

T1 - A multicentre, randomised, sham-controlled trial on REmote iSchemic conditioning In patients with acute STroke (RESIST) – Rationale and study design

AU - Blauenfeldt, Rolf A.

AU - Hjort, Niels

AU - Gude, Martin F.

AU - Behrndtz, Anne B.

AU - Fisher, Marc

AU - Valentin, Jan B.

AU - Kirkegaard, Hans

AU - Johnsen, Søren P.

AU - Hess, David C.

AU - Andersen, Grethe

PY - 2020

Y1 - 2020

N2 - Rationale: Remote ischaemic conditioning, applied in the prehospital setting and continued in-hospital, may improve functional outcome in patients with acute ischaemic stroke and intracerebral haemorrhage. Aims: To evaluate whether combined remote ischaemic per- and postconditioning can improve long-term functional outcome in acute ischaemic stroke and intracerebral haemorrhage patients. Methods and design: Danish multicentre, prospective, randomised, patient-assessor blinded, sham-controlled study. Adult patients with a putative stroke identified prehospital with symptom duration <4 h, who are independent in daily activities will be randomised 1:1 to remote ischaemic conditioning or Sham-remote ischaemic conditioning. The treatment protocol will be five cycles, each consisting of 5 min with a blood pressure cuff inflation and 5 min with a deflated cuff placed on the upper extremity. The cuff pressure for remote ischaemic conditioning will be 200 mmHg–285 mmHg according to the individual systolic blood pressure and 20 mmHg sham-remote ischaemic conditioning during inflation. The study is approved as an acute study and consent is waived in the acute phase. Sample size estimation: For a 7% increased odds for a beneficial shift on the modified Rankin Scale at a significance level of 5% and power of 90%, 1000 patients with a target diagnosis of acute ischaemic stroke and intracerebral haemorrhage and a total of 1500 patients with a prehospital presumed stroke will be included. Study outcomes: The primary outcome will be the modified Rankin Scale score measured at three-month follow-up (analysed using ordinal logistic regression). ClinicalTrials.gov Identifier: NCT03481777.

AB - Rationale: Remote ischaemic conditioning, applied in the prehospital setting and continued in-hospital, may improve functional outcome in patients with acute ischaemic stroke and intracerebral haemorrhage. Aims: To evaluate whether combined remote ischaemic per- and postconditioning can improve long-term functional outcome in acute ischaemic stroke and intracerebral haemorrhage patients. Methods and design: Danish multicentre, prospective, randomised, patient-assessor blinded, sham-controlled study. Adult patients with a putative stroke identified prehospital with symptom duration <4 h, who are independent in daily activities will be randomised 1:1 to remote ischaemic conditioning or Sham-remote ischaemic conditioning. The treatment protocol will be five cycles, each consisting of 5 min with a blood pressure cuff inflation and 5 min with a deflated cuff placed on the upper extremity. The cuff pressure for remote ischaemic conditioning will be 200 mmHg–285 mmHg according to the individual systolic blood pressure and 20 mmHg sham-remote ischaemic conditioning during inflation. The study is approved as an acute study and consent is waived in the acute phase. Sample size estimation: For a 7% increased odds for a beneficial shift on the modified Rankin Scale at a significance level of 5% and power of 90%, 1000 patients with a target diagnosis of acute ischaemic stroke and intracerebral haemorrhage and a total of 1500 patients with a prehospital presumed stroke will be included. Study outcomes: The primary outcome will be the modified Rankin Scale score measured at three-month follow-up (analysed using ordinal logistic regression). ClinicalTrials.gov Identifier: NCT03481777.

KW - Acute ischaemic stroke

KW - intracerebral haemorrhage

KW - neuroprotection

KW - perconditioning

KW - postconditioning

KW - prehospital

KW - remote ischaemic conditioning

UR - http://www.scopus.com/inward/record.url?scp=85074583964&partnerID=8YFLogxK

U2 - 10.1177/2396987319884408

DO - 10.1177/2396987319884408

M3 - Journal article

C2 - 32232175

AN - SCOPUS:85074583964

VL - 5

SP - 94

EP - 101

JO - European Stroke Journal

JF - European Stroke Journal

SN - 2396-9873

IS - 1

ER -