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

Rolf A. Blauenfeldt, Niels Hjort, Martin F. Gude, Anne B. Behrndtz, Marc Fisher, Jan B. Valentin, Hans Kirkegaard, Søren P. Johnsen, David C. Hess, Grethe Andersen

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)94-101
Number of pages8
JournalEuropean Stroke Journal
Volume5
Issue number1
DOIs
StatePublished - Mar 1 2020

Keywords

  • Acute ischaemic stroke
  • intracerebral haemorrhage
  • neuroprotection
  • perconditioning
  • postconditioning
  • prehospital
  • remote ischaemic conditioning

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine

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