Remote Ischemic PreConditioning (RIPC)

NCT03814850 | Withdrawn DMC FDA Device

• 2 other identifiers: 2019128220180869
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Unruptured Cerebral Aneurysm

Keywords

brain aneurysm; endovascular repair; ischemic stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Change in procedurally-induced vascular cognitive impairment.

  Baseline, 3-9 months.

• Volume of embolic strokes by Diffusion Weighted Imaging (DWI).

  Timeframe: Baseline, 12-96 hours post procedures

• Volume of embolic strokes by Fluid-attenuated Inversion Recovery (FLAIR).

  Timeframe: Baseline, 12-96 hours post procedures.

• Frequency of large (>10 cc value) strokes.

  2-4 days post procedures.

Study Arms (2)

Treatment group: standard blood pressure cuff

EXPERIMENTAL

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

Sham group: standard blood pressure cuff

SHAM COMPARATOR

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

Interventions

Standard Manual Aneroid Sphygmomanometer DEVICE

Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.

Sham group: standard blood pressure cuff; Treatment group: standard blood pressure cuff

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sebastian Koch: lead

Study Sites (2)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Starke, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

• Sebastian Koch, MD

  University of Miami

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person performing the RIPC is not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Neurology

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 24, 2019
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)