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Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment (RIPAT)

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ClinicalTrials.gov Identifier: NCT02162654
Recruitment Status : Unknown
Verified June 2014 by Martin Ortler, MD MSc, Medical University Innsbruck.
Recruitment status was:  Recruiting
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Martin Ortler, MD MSc, Medical University Innsbruck

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Aneurysm Procedure: Remote ischemic preconditioning Procedure: Sham preconditioning Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Remote Ischemic Preconditioning in the Prevention of Ischemic Brain Damage During Intracranial Aneurysm Treatment (RIPAT) - A Prospective Randomized Exploratory Study
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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 Comparator: 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.




Primary Outcome Measures :
  1. Area-under-Curve for biomarkers in the first 5 days after aneurysm treatment(S100B, NSE, GFAP, NSE, MMP9, Microparticles) [ Time Frame: 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)


Secondary Outcome Measures :
  1. Number (n) of new lesions in postinterventional MRI (DWI and FLAIR) [ Time Frame: preinterventional/on day 1 or 2 ]
    Outcome Parameter used in other clinical studies focussing on ischemia after neurointerventional procedures (e.g. ENACT study)

  2. Clinical outcome ( National Institutes of Health Stroke Scale, NIHSS and modified Rankin Scale mRS) [ Time Frame: at discharge, at 6 and 12 months ]
    Established outcome parameters for cerebrovascular studies. Dichotomized into favourable (NIHSS ≤1, mRS 0-1) and unfavourable

  3. Volume (mm3) of new lesions in postinterventional MRI (DWI and FLAIR) [ Time Frame: preinterventional, postinterventional on day 1 or 2 ]
    As above for number of lesions


Other Outcome Measures:
  1. 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) [ Time Frame: preinterventional, at 6 and 12 months ]
    Standard tests used in patients with cerebrovascular disorders in our departments. Not applicable to non-german-speaking patients.

  2. Brain volume changes (MRI, voxel -based morphometry) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162654


Contacts
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Contact: Martin Ortler, M.D., MSc. 0043-512-504 ext 80975 martin.ortler@i-med.ac.at
Contact: Claudius Thomé, M.D. 0043-512-504 ext 27452 claudius.thome@i-med.ac.at

Locations
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Austria
Clinical Department of Neurosurgery, Innsbruck Medical University Recruiting
Innsbruck, Austria, 6020
Contact: Martin Ortler, M.D., MSc.    0043-512-504 ext 80975    martin.ortler@i-med.ac.at   
Contact: Selma Tülü, Cand. med.       selma.tuelue@student.i-med.ac.at   
Principal Investigator: Martin Ortler, MD, MSc         
Sub-Investigator: Claudius Thomé, M.D.         
Sub-Investigator: Selma Tülü, Cand.med.         
Sub-Investigator: Miriam Mulino, M.D.         
Sub-Investigator: Daniel Pinggera, M.D.         
Sub-Investigator: Claudia Unterhofer, M.D.         
Sub-Investigator: Erich Schmutzhard, M.D.         
Sub-Investigator: Bettina Pfausler, M.D.         
Sub-Investigator: Ronny Beer, M.D.         
Sub-Investigator: Raimund Helbok, M.D.         
Sub-Investigator: Peter Lackner, M.D.         
Sub-Investigator: Thomas Benke, M.D.         
Sub-Investigator: Thomas Bodner, M.D.         
Sub-Investigator: Margarethe Delazer, M.D.         
Sub-Investigator: Raffaella Matteucci-Gothe, Ph.D.         
Sub-Investigator: Uwe Siewert, Ph.D.         
Sub-Investigator: Philipp Würtinger, M.D.         
Sub-Investigator: Andrea Griesmacher, M.D.         
Sub-Investigator: Markus Luger, M.D.         
Sub-Investigator: Arnulf Benzer, M.D.         
Sub-Investigator: Franz Wiedermann, M.D.         
Sub-Investigator: Astrid Grams, M.D.         
Sub-Investigator: Elke Gizewski, M.D.         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Martin Ortler, M.D., MSc. Clinical Department of Neurosurgery, Innsbruck Medical University

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Responsible Party: Martin Ortler, MD MSc, Vice Chairman, Clinical Department of Neurosurgery, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02162654     History of Changes
Other Study ID Numbers: 20131101-823
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014

Keywords provided by Martin Ortler, MD MSc, Medical University Innsbruck:
neuroprotection
ischemic preconditioning
cerebral aneurysm

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases