Remote Ischemic PreConditioning (RIPC)



Status:Not yet recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:June 7, 2019
End Date:September 7, 2022
Contact:Robert Starke, M.D.
Email:RStarke@med.miami.edu
Phone:305-355-1101

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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.


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.
We found this trial at
2
sites
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Robert Starke, M.D.
Phone: 305-585-2099
University of Miami A private research university with more than 15,000 students from around the...
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
Phone: 305-585-2099
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