Remote Ischemic PreConditioning (RIPC)

Unruptured Cerebral Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03814850
• Other study ID #: 20191282
• Secondary ID: 20180869
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß-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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Unruptured Cerebral Aneurysm

Intervention

Device:
• Standard Manual Aneroid Sphygmomanometer
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sebastian Koch

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all adverse events and serious adverse events.	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
Primary	Change in procedurally-induced vascular cognitive impairment.	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	Change in procedurally-induced vascular cognitive impairment.	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.
Secondary	Volume of embolic strokes by Diffusion Weighted Imaging (DWI).	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
Secondary	Volume of embolic strokes by Fluid-attenuated Inversion Recovery (FLAIR).	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.
Secondary	Frequency of large (>10 cc value) strokes.	As measured by MRI imaging when performed.	2-4 days post procedures.