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Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment (RIPAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date June 13, 2014
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 11, 2014)
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment
Official Title  ICMJE The Role of Remote Ischemic Preconditioning in the Prevention of Ischemic Brain Damage During Intracranial Aneurysm Treatment (RIPAT) - A Prospective Randomized Exploratory Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cerebral Aneurysm
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Remote ischemic preconditioning
  • 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
    Intervention: Procedure: Sham preconditioning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162654
Other Study ID Numbers  ICMJE 20131101-823
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Ortler, MD MSc, Medical University Innsbruck
Study Sponsor  ICMJE Medical University Innsbruck
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Ortler, M.D., MSc. Clinical Department of Neurosurgery, Innsbruck Medical University
PRS Account Medical University Innsbruck
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP