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Remote Ischemic PreConditioning (RIPC)

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ClinicalTrials.gov Identifier: NCT03814850
Recruitment Status : Not yet recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Starke, University of Miami

Brief Summary:
The purpose of this study is to learn about protecting the brain from low blood flow (ischemia) with limb preconditioning. From human studies the investigators know that the brain can be protected from dangerous low blood flow by reducing the blood flow to an arm or leg for just a short period of time. This is called limb preconditioning. The investigators are studying the safety and feasibility of preconditioning and their effect of protecting the brain from ischemia in two different groups. This is a Phase 2, randomized, double-blind, sham-controlled, design. Up to 50 male and female patients undergoing elective endovascular repair of unruptured brain aneurysm who are randomized to the remote ischemic preconditioned or sham group will be enrolled. This study consists of one 3-9 month study period for each patient plus up to 14 days for enrollment activities. Subjects are required to return between 3-9 months for end-of-study procedures.

Condition or disease Intervention/treatment Phase
Unruptured Cerebral Aneurysm Device: Standard Manual Aneroid Sphygmomanometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The person performing the RIPC is not blinded.
Primary Purpose: Supportive Care
Official Title: Remote Ischemic PreConditioning Provides Neuroprotection: A Phase 2, Single Center, Randomized, Double-Blind, Sham-Controlled, Safety and Efficacy Study Evaluating the Use of Remote Ischemic Preconditioning in Patients Undergoing Endovascular Repair of Brain Aneurysms
Estimated Study Start Date : June 7, 2019
Estimated Primary Completion Date : September 7, 2022
Estimated Study Completion Date : September 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Treatment group: standard blood pressure cuff
A standard blood pressure cuff inflated on the participants arm for 4 cycles; each cycle will include 5 minutes of inflation followed by 5 minutes of deflection. RIPC will be applied via a standard blood pressure cuff. The ischemic cycle will involve cuff inflating to 30mmHg above resting systolic blood pressure and demonstration of loss of radial pulse.
Device: Standard Manual Aneroid Sphygmomanometer
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.

Sham Comparator: Sham group: standard blood pressure cuff
The blood pressure cuff will be inflated to 30mmHg during the first 5 minutes of each cycle and deflated for the following 5 minutes, with re-demonstration of radial pulse. This will be repeated for 4 cycles.
Device: Standard Manual Aneroid Sphygmomanometer
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.




Primary Outcome Measures :
  1. Incidence of all adverse events and serious adverse events. [ Time Frame: 9 months ]
    Adverse events are all conditions/symptoms/findings and all abnormal clinically significant laboratory tests both expected and unexpected, occurring from onset of the intervention until study completion.

  2. Change in procedurally-induced vascular cognitive impairment. [ Time Frame: Baseline, Day 2-4 ]
    As measured by the NIH-toolbox for neurocognitive testing.NIH-Toolbox normalized scores to define a single cognitive battery index.C. Score:0= No deficit, no change; 400= Maximum deficit.


Secondary Outcome Measures :
  1. Change in procedurally-induced vascular cognitive impairment. [ Time Frame: Baseline, 3-9 months. ]
    As measured by the NIH-toolbox for neurocognitive testing. NIH-Toolbox normalized scores to define a single cognitive battery index.C. Score:0= No deficit, no change; 400= Maximum deficit

  2. Volume of embolic strokes by Diffusion Weighted Imaging (DWI). [ Time Frame: Timeframe: Baseline, 12-96 hours post procedures ]
    Measured in select patients by Diffusion Weighted Imaging (DWI) via Magnetic Resonance Imaging (MRI) that undergo 4 cycles of 5 minutes of limb ischemia followed by 5 minutes reperfusion.

  3. Volume of embolic strokes by Fluid-attenuated Inversion Recovery (FLAIR). [ Time Frame: Timeframe: Baseline, 12-96 hours post procedures. ]
    Measured in select patients by Fluid-attenuated Inversion Recovery (FLAIR) via Magnetic Resonance Imaging (MRI) that undergo 4 cycles of 5 minutes of limb ischemia followed by 5 minutes reperfusion.

  4. Frequency of large (>10 cc value) strokes. [ Time Frame: 2-4 days post procedures. ]
    As measured by MRI imaging when performed.



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:

  1. A diagnosis of an unruptured brain aneurysm deemed suitable for repair by neuroendovascular techniques involving intraluminal occlusion by detachable platinum coils, stent-assisted coiling, pipeline stent, balloon-assisted coiling, covered stent only, neck-bridge device, re-coiling, or re-treatment of a previously coiled/treated aneurysm. There are no restrictions on adjunctive devices.
  2. Absence of ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, stroke-in-evolution, or clinical evidence of cerebral vasospasm within 2 weeks prior to randomization. (If a CT scan, cerebral angiogram, or other imaging performed during the 2 weeks prior to randomization shows radiological vasospasm deemed by the treating physician to be potentially clinically significant, the subject is excluded).
  3. Male or female with a minimum age of 18 years on the day of enrollment.
  4. Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.

Exclusion Criteria:

  1. Dissecting or mycotic brain aneurysm. Fusiform or atherosclerotic intracerebral aneurysms may be eligible for the trial if endovascular treatment is planned with a goal of exclusion of the aneurysm from the circulation.
  2. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
  3. Known history of life-threatening allergic reaction to any medication.
  4. Soft tissue, orthopedic, or vascular injury which, in the judgment of the investigator, would preclude arm ischemic conditioning (e.g. superficial wounds, venous, arterial ulcers, gangrene).
  5. History of peripheral vascular disease or deep vein thrombosis in either arm.
  6. Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
  7. Women who are breastfeeding.
  8. Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
  9. Pre-morbid (estimated) modified Rankin scale score of greater than 2. A subject is not excluded if they have a pre-morbid modified Rankin scale of greater than 2 but the disability does not interfere with the subject's ability to complete an MRI and the cognitive evaluations.
  10. Previous serious traumatic brain injury that would preclude the patient from completing the protocol or preclude MRI analysis of small strokes.
  11. Patients with peripherally inserted central catheters, hemodialysis shunts, arteriovenous fistulae or grafts in the treatment limb, or lymphedema.
  12. Patients with known Human Immunodeficiency Virus (HIV) infection.
  13. Patients who are unable to have an MRI scan for any reason.
  14. Participation in a clinical trial with an investigational drug within 30 days preceding this study. Previous participation in any clinical trial investigating ischemia following endovascular aneurysm treatment, participation in another trial involving RIPC, or prior receipt of RIPC.
  15. Severe or unstable concomitant condition disease or chronic condition, which, in the opinion of the investigator, could affect assessment of the safety or efficacy of study intervention.
  16. Any other medical condition that the site investigator deems would put the patient at excessive risk of participation in the study or an expected life expectancy less than 1 year or that would result in inability to collect clinical outcomes at 30 days.
  17. Systolic blood pressure above 200mm Hg.
  18. Cannot tolerate inflation of the tourniquet on their arm consistent with blood pressure cuff.

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): NCT03814850


Contacts
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Contact: Robert Starke, M.D. 305-355-1101 RStarke@med.miami.edu

Locations
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United States, Florida
Jackson Memorial Hospital Not yet recruiting
Miami, Florida, United States, 33136
Contact: Lutecia M Pereira, Ph.D.    305-585-2099    lpereira@miami.edu   
Contact: Robert Starke, M.D.    305-355-1101    RStarke@med.miami.edu   
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Lutecia M Pereira, Ph.D    305-585-2099    lpereira@miami.edu   
Contact: Robert Starke, M.D.    305-355-1101    RStarke@med.miami.edu   
Principal Investigator: Robert Starke, M.D.         
Sponsors and Collaborators
Robert Starke
Investigators
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Principal Investigator: Robert Starke, M.D. University of Miami

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Responsible Party: Robert Starke, Assistant Professor of Clinical Neurosurgery, University of Miami
ClinicalTrials.gov Identifier: NCT03814850     History of Changes
Other Study ID Numbers: 20180869
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Robert Starke, University of Miami:
brain aneurysm
endovascular repair
ischemic stroke

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