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Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment (RIPAT)

11. juni 2014 opdateret af: Martin Ortler, MD MSc, Medical University Innsbruck

The Role of Remote Ischemic Preconditioning in the Prevention of Ischemic Brain Damage During Intracranial Aneurysm Treatment (RIPAT) - A Prospective Randomized Exploratory Study

The RIPAT study is a prospective, randomized, double-blind study organized by the neurovascular group of the Clinical Department of Neurosurgery of Innsbruck Medical University, Innsbruck, Austria. Patients aged 18+ in whom the treatment of an un-ruptured intracranial aneurysm is indicated are eligible for study participation. Prior to aneurysm treatment, with the patient already under general anesthesia, the blood supply to an arm will be restricted for 3x 5minutes by inflating a standard blood pressure cuff. The study hypothesis is that this "remote ischemic preconditioning" maneuver is able to prevent a stroke during the following treatment of the aneurysm.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Prospective, randomized, double-blind, explorative single center clinical trial in patients subjected to the treatment of an un-ruptured intracranial aneurysm, either by surgical clipping or endovascular coiling. Goal of the study is to determine whether remote ischemic preconditioning (RIPC) prior to aneurysm treatment alters various biomarkers associated with ischemic central neuronal tissue damage. The trial takes place at Innsbruck University Hospital of Innsbruck Medical University, Innsbruck, Austria.

Patients fulfilling inclusion criteria are randomly allocated either to pre-interventional ischemic preconditioning (Group A = intervention group) or sham preconditioning (Group B = control group). RIPC is performed by inflating a blood pressure cuff around one upper extremity three times for five minutes with five minutes interval with the patient under general anesthesia prior to the start of the procedure.

Patients, all staff involved in diagnosis and treatment and all study members are blinded to the patients' group affiliation. The anesthesiologist and two staff members who perform preconditioning are not blinded.

Primary outcome is a difference of ± 2SD in the concentration-time curve of a panel of biochemical parameters indicative of cerebral ischemia (S100B, NSE, GFAP, MMP9, MBP, microparticles) in the first five days after the intervention. Secondary outcome parameters are changes in the post-interventional MRI and neuropsychological and clinical outcome at six and 12 months.

CONSORT and TIDieR guidelines will be followed. The trail will be registered in a public database. The trail protocol will be published in an open-access journal.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Østrig
      • Innsbruck, Østrig, 6020
        • Rekruttering
        • Clinical Department of Neurosurgery, Innsbruck Medical University
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Martin Ortler, MD, MSc
        • Underforsker:
          • Claudius Thomé, M.D.
        • Underforsker:
          • Selma Tülü, Cand.med.
        • Underforsker:
          • Miriam Mulino, M.D.
        • Underforsker:
          • Daniel Pinggera, M.D.
        • Underforsker:
          • Claudia Unterhofer, M.D.
        • Underforsker:
          • Erich Schmutzhard, M.D.
        • Underforsker:
          • Bettina Pfausler, M.D.
        • Underforsker:
          • Ronny Beer, M.D.
        • Underforsker:
          • Raimund Helbok, M.D.
        • Underforsker:
          • Peter Lackner, M.D.
        • Underforsker:
          • Thomas Benke, M.D.
        • Underforsker:
          • Thomas Bodner, M.D.
        • Underforsker:
          • Margarethe Delazer, M.D.
        • Underforsker:
          • Raffaella Matteucci-Gothe, Ph.D.
        • Underforsker:
          • Uwe Siewert, Ph.D.
        • Underforsker:
          • Philipp Würtinger, M.D.
        • Underforsker:
          • Andrea Griesmacher, M.D.
        • Underforsker:
          • Markus Luger, M.D.
        • Underforsker:
          • Arnulf Benzer, M.D.
        • Underforsker:
          • Franz Wiedermann, M.D.
        • Underforsker:
          • Astrid Grams, M.D.
        • Underforsker:
          • Elke Gizewski, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Informed written consent of patient
  • Age > 18 years
  • Intracranial aneurysm, single or multiple, intervention as indicated by interdisciplinary vascular board (includes previously treated aneurysms)
  • Normal baseline MRI

Exclusion Criteria:

  • Clinical or radiological signs of subarachnoid hemorrhage
  • Planned vessel sacrifice as the primary modality for aneurysm treatment
  • Dissecting or mycotic aneurysm
  • Previous history of stroke or TIA within the last six months
  • Signs or symptoms of upper and lower extremity peripheral vascular illness
  • Drugs and lifestyle factors that interfere with biomarker Determination
  • Inability to complete neuropsychological testing for language reasons
  • Patients unable to have an MRI scan for any reason
  • Previous serious cerebral disease that would preclude completion of the protocol or preclude MRI analysis of small strokes
  • Pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Remote ischemic preconditioning
Inflation of a blood pressure cuff around an arm with the patient under general anesthesia prior to start aneurysm treatment
Procedure: Remote ischemic preconditioning
The blood pressure cuff is inflated to 200 mmHg for 3 x 5 minutes with 5 minutes of reperfusion by complete cuff deflation each.
Sham-komparator: Sham preconditioning
Sham inflation of a blood pressure cuff around an arm with the patient under general anesthesia prior to start aneurysm treatment
Procedure: Sham preconditioning
The blood pressure cuff is inflated to 10 mmHg for 3 x 5 minutes with 5 minutes of complete cuff deflation each.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area-under-Curve for biomarkers in the first 5 days after aneurysm treatment(S100B, NSE, GFAP, NSE, MMP9, Microparticles)
Tidsramme: on admission, after preconditioning but prior to intervention, at completion of intervention, at hours 3, 6, 12, 24, 48, 72, 96, 120 after completion of intervention
Serum biomarkers reflect brain tissue ischemic damage with various specificity and sensitivity (see Whiteley 2008, Ahmad 2012) Advantages include (1) to be available early, (2) to be continuous variables (low study n), (3) they were able to demonstrate an effect of ischemic preconditioning in other clinical studies (see Koch 2010, Veighei 2012)
on admission, after preconditioning but prior to intervention, at completion of intervention, at hours 3, 6, 12, 24, 48, 72, 96, 120 after completion of intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number (n) of new lesions in postinterventional MRI (DWI and FLAIR)
Tidsramme: preinterventional/on day 1 or 2
Outcome Parameter used in other clinical studies focussing on ischemia after neurointerventional procedures (e.g. ENACT study)
preinterventional/on day 1 or 2
Clinical outcome ( National Institutes of Health Stroke Scale, NIHSS and modified Rankin Scale mRS)
Tidsramme: at discharge, at 6 and 12 months
Established outcome parameters for cerebrovascular studies. Dichotomized into favourable (NIHSS ≤1, mRS 0-1) and unfavourable
at discharge, at 6 and 12 months
Volume (mm3) of new lesions in postinterventional MRI (DWI and FLAIR)
Tidsramme: preinterventional, postinterventional on day 1 or 2
As above for number of lesions
preinterventional, postinterventional on day 1 or 2

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neuropsychological testing VLMTA (Verbaler Lern- und Merkfähigkeitstest), the WMS-R (Zahlenspanne vorwärts und rückwärts), trail making A and B tests, the Regensburger Wortflüssigkeitstest, the TAP Wechsel verbal, the TAP and the HADS-D)
Tidsramme: preinterventional, at 6 and 12 months
Standard tests used in patients with cerebrovascular disorders in our departments. Not applicable to non-german-speaking patients.
preinterventional, at 6 and 12 months
Brain volume changes (MRI, voxel -based morphometry)
Tidsramme: Preinterventional/at the 12 months FU
Longterm brain volume changes that correlate with NP deficits (Horstmann 2010, Moskowitz 2011, Vuylsteke 2011) will be analyzed using voxel-based morphometry techniques
Preinterventional/at the 12 months FU

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University Innsbruck

Efterforskere

  • Ledende efterforsker: Martin Ortler, M.D., MSc., Clinical Department of Neurosurgery, Innsbruck Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2013

Primær færdiggørelse (Forventet)

1. november 2015

Studieafslutning (Forventet)

1. november 2016

Datoer for studieregistrering

Først indsendt

10. juni 2014

Først indsendt, der opfyldte QC-kriterier

11. juni 2014

Først opslået (Skøn)

13. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20131101-823

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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