Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment

NCT02162654 | Unknown

• 1 other identifier: 20131101-823
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Aneurysm

Keywords

neuroprotection; ischemic preconditioning; cerebral aneurysm

Outcome Measures

Primary Outcomes (1)

• Area-under-Curve for biomarkers in the first 5 days after aneurysm treatment(S100B, NSE, GFAP, NSE, MMP9, Microparticles)

  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

Secondary Outcomes (3)

• Number (n) of new lesions in postinterventional MRI (DWI and FLAIR)

  preinterventional/on day 1 or 2

• Clinical outcome ( National Institutes of Health Stroke Scale, NIHSS and modified Rankin Scale mRS)

  at discharge, at 6 and 12 months

• Volume (mm3) of new lesions in postinterventional MRI (DWI and FLAIR)

  preinterventional, postinterventional on day 1 or 2

Other Outcomes (2)

• 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)

  preinterventional, at 6 and 12 months

• Brain volume changes (MRI, voxel -based morphometry)

  Preinterventional/at the 12 months FU

Study Arms (2)

Remote ischemic preconditioning

ACTIVE COMPARATOR

Inflation of a blood pressure cuff around an arm with the patient under general anesthesia prior to start aneurysm treatment

Procedure: Remote ischemic preconditioning

Sham preconditioning

SHAM COMPARATOR

Sham inflation of a blood pressure cuff around an arm with the patient under general anesthesia prior to start aneurysm treatment

Procedure: Sham preconditioning

Interventions

Remote ischemic preconditioning PROCEDURE

The blood pressure cuff is inflated to 200 mmHg for 3 x 5 minutes with 5 minutes of reperfusion by complete cuff deflation each.

Remote ischemic preconditioning

Sham preconditioning PROCEDURE

The blood pressure cuff is inflated to 10 mmHg for 3 x 5 minutes with 5 minutes of complete cuff deflation each.

Sham preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Clinical Department of Neurosurgery, Innsbruck Medical University

Innsbruck, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martin Ortler, M.D., MSc.

  Clinical Department of Neurosurgery, Innsbruck Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Ortler, M.D., MSc.

CONTACT

0043-512-504; martin.ortler@i-med.ac.at

Claudius Thomé, M.D.

CONTACT

0043-512-504; claudius.thome@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman, Clinical Department of Neurosurgery

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2016
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

AU (1)