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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

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.

OriginalsprogEngelsk
TidsskriftEuropean Stroke Journal
ISSN2396-9873
DOI
StatusE-pub ahead of print - 2019

Fingerprint

Randomized Controlled Trials
Stroke
Cerebral Hemorrhage
Economic Inflation
Blood Pressure
Ischemic Postconditioning
Clinical Protocols
Upper Extremity
Sample Size
Logistic Models
Outcome Assessment (Health Care)
Pressure

Citer dette

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. / A multicentre, randomised, sham-controlled trial on REmote iSchemic conditioning In patients with acute STroke (RESIST) – Rationale and study design. I: European Stroke Journal. 2019.
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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.",
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 = "2019",
doi = "10.1177/2396987319884408",
language = "English",
journal = "European Stroke Journal",
issn = "2396-9873",
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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, 2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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 - 2019

Y1 - 2019

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.

U2 - 10.1177/2396987319884408

DO - 10.1177/2396987319884408

M3 - Journal article

JO - European Stroke Journal

JF - European Stroke Journal

SN - 2396-9873

ER -