Status:
COMPLETED
Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
San Gerardo Hospital
Università degli Studi dell'Aquila
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Phase II, prospective, randomized, multicenter, open-label, pilot clinical trial comparing remote ischemic conditioning (RIC) plus standard medical therapy to standard medical therapy alone, in patien...
Detailed Description
Funding: This study is supported by a grant from the Ministry of Health: PRIN 2017CY3J3W. This funding source had no role in the design of this study and will not have any role during its execution, a...
Eligibility Criteria
Inclusion
- Clinical diagnosis and/or diagnosis on neuromaging of anterior circulation acute ischemic stroke (due to either large or small vessel occlusion) within 9 hours of symptom onset. Information regarding time of stroke onset will be obtained by patient, family member or anyone present at the time of stroke onset or by the emergency medical technician in case the patient is brought to the Emergency Department by the Emergency Medical Services
- Age ≥ 18 years
- Neurologic deficit with National Institutes of Health Stroke Scale (NIHSS) ≥5 and \<25
- Informed consent obtained from patient whenever possible, or by family member, or legally responsible person in other cases
- Stroke with Unknown Time of Onset: the patient either recognized stroke symptoms on awakening or could not report the timing of the onset of symptoms due to neurological deficits (e.g., as a result of aphasia, anarthria, confusion). For patients who recognized stroke symptoms on awakening, onset was estimated as the midpoint of sleep (i.e., the time between going to sleep and waking up with symptoms) and patients underwent randomization if they were within 9 hours of the estimated time of onset. For patients who could not report the timing of symptom onset, the time that had elapsed since the patient was last known to be well had to be \<9 hours. Information regarding time of going to sleep or last time the patient was seen well will be obtained by patient, family member or anyone who had the last contact with the patient before stroke onset.
- Modified Rankin Scale≤2 prior to stroke onset
Exclusion
- Patients that are candidates for thrombolysis and/or thrombectomy according to AHA/ASA guidelines
- CT Head or brain MRI detecting intracranial hemorrhage, vascular malformation, intracranial masses or any other pathology that could explain symptoms
- Rapidly improving neurological symptoms at the time of first evaluation, judged by the attending Physician (Ref: Clotilde Balucani et al. Rapidly Improving Stroke Symptoms: A Pilot, Prospective Study. J Stroke Cerebrovasc Dis, 24 (6), 1211-6 Jun 2015 )
- Transient Ischemic Attack (TIA), with resolution of symptoms at the time of first evaluation
- Amputation of the upper non paretic arm
- Presence of any ulcer or a bad skin condition in the upper or lower limbs
- History of arterial occlusive disease, sickle cell disease (due to the risk of vaso-occlusive crisis), or upper limb phlebitis
- Pregnancy
- Ongoing participation in any interventional study
- Unavailability for follow-up
- Advanced or terminal illness, judged by the attending Physician, that could make unlikely patient's availability for follow up at 3 months or life expectancy less than 6 months
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04400981
Start Date
August 1 2021
End Date
August 30 2024
Last Update
December 12 2024
Active Locations (4)
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1
Ospedale Civile SS. Filippo e Nicola di Avezzano
Avezzano, L'Aquila, Italy, 67051
2
Ospedale Sant'Andrea
Rome, Lazio, Italy, 00189
3
Ospedale San Gerardo
Monza, Lombardy, Italy, 20900
4
IRCCS Fondazione Istituto Neurologico Mondino
Pavia, Pavia, Italy, 27100