- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814850
Remote Ischemic PreConditioning (RIPC)
December 1, 2023 updated by: Sebastian Koch
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robert Starke, M.D.
- Phone Number: 305-355-1101
- Email: RStarke@med.miami.edu
Study Contact Backup
- Name: Sebastian Koch, MD
- Phone Number: 305 243-6732
- Email: skoch@med.miami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
Contact:
- Anabela M Cieslicki
- Phone Number: 305-243-8044
- Email: axc1623@med.miami.edu
-
Contact:
- Robert Starke, M.D.
- Phone Number: 305-355-1101
- Email: RStarke@med.miami.edu
-
Principal Investigator:
- Robert Starke, M.D.
-
Miami, Florida, United States, 33136
- Jackson Memorial Hospital
-
Contact:
- Anabela M Cieslicki
- Phone Number: 305-243-8044
- Email: axc1623@med.miami.edu
-
Contact:
- Robert Starke, M.D.
- Phone Number: 305-355-1101
- Email: RStarke@med.miami.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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).
- Male or female with a minimum age of 18 years on the day of enrollment.
- 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:
- 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.
- Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment.
- Known history of life-threatening allergic reaction to any medication.
- 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).
- History of peripheral vascular disease or deep vein thrombosis in either arm.
- Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
- Women who are breastfeeding.
- Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
- 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.
- Previous serious traumatic brain injury that would preclude the patient from completing the protocol or preclude MRI analysis of small strokes.
- Patients with peripherally inserted central catheters, hemodialysis shunts, arteriovenous fistulae or grafts in the treatment limb, or lymphedema.
- Patients with known Human Immunodeficiency Virus (HIV) infection.
- Patients who are unable to have an MRI scan for any reason.
- 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.
- 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.
- 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.
- Systolic blood pressure above 200mm Hg.
- Cannot tolerate inflation of the tourniquet on their arm consistent with blood pressure cuff.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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.
|
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9 months
|
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.
|
Baseline, Day 2-4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 3-9 months.
|
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.
|
Timeframe: Baseline, 12-96 hours post procedures
|
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.
|
Timeframe: Baseline, 12-96 hours post procedures.
|
Frequency of large (>10 cc value) strokes.
Time Frame: 2-4 days post procedures.
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As measured by MRI imaging when performed.
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2-4 days post procedures.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Starke, M.D., University of Miami
- Study Director: Sebastian Koch, MD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
January 16, 2019
First Submitted That Met QC Criteria
January 22, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Estimated)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 1, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20191282
- 20180869 (Other Identifier: University of Miami IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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