Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2024-12-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Standard Manual Aneroid Sphygmomanometer
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.
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.
Standard Manual Aneroid Sphygmomanometer
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard Manual Aneroid Sphygmomanometer
Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sebastian Koch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sebastian Koch
Professor of Clinical Neurology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Starke, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Sebastian Koch, MD
Role: STUDY_DIRECTOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jackson Memorial Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20180869
Identifier Type: OTHER
Identifier Source: secondary_id
20191282
Identifier Type: -
Identifier Source: org_study_id