Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies (TRICS-9)
Ischemic Stroke
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring remote ischemic conditioning, acute ischemic stroke, neuroprotection
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Ospedale Civile SS. Filippo e Nicola di AvezzanoRecruiting
- Ospedale Sant'AndreaRecruiting
- Ospedale San GerardoRecruiting
- IRCCS Fondazione Istituto Neurologico MondinoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention arm: RIC plus standard medical therapy
Control arm: Standard medical therapy alone
Remote ischemic conditioning (RIC) will be applied immediately after randomization in the Emergency Department, through a standard blood pressure cuff placed around the non-paretic arm. The protocol includes 4 cycles of intermittent manually induced upper limb ischemia, alternating 5 minutes of inflation (20mmHg above systolic blood pressure) and 5 minutes of deflation. Patients randomized to remote ischemic conditioning will also receive standard medical therapy
Standard medical therapy will be administered immediately after randomization in the Emergency Department. Standard medical therapy comprises single antiplatelet therapy, either aspirin given in a total dose ranging between 100 to 300 mg per day on days 1-5 and followed by aspirin 100mg/day on days 1-5 followed by aspirin 100mg/day, or Clopidogrel 75mg/day (at the discretion of the patient's attending physician), unless an indication for early anticoagulation (e.g. atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state) or dual antiplatelet therapy (e.g. early carotid stenting) is present. All patients will receive standard deep venous thrombosis (DVT) prevention therapy together with appropriate treatment for blood pressure control, glycemic control and cholesterol reduction.