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 post 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.

Ischemic Stroke

Remote ischemic conditioning 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.

Remote ischemic conditioning

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.

standard medical therapy

Ospedale Civile SS. Filippo e Nicola di Avezzano

Ospedale Sant'Andrea

Ospedale San Gerardo

Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies

Multi-center Randomized Pilot Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies

The primary efficacy outcome is the proportion of patients with large clinical benefit (NIHSS score reduction ≥ 8 points compared to baseline NIHSS score or achievement of a NIHSS score of 0-1 at 72 hours) after 72 hours of randomization.

Proportion of patients with large clinical benefit (NIHSS score reduction ≥ 8 points compared to baseline NIHSS score or achievement of a NIHSS score of 0-1 at 2 hours) after 24 hours of randomization.

Proportion of patients with large clinical benefit (NIHSS score reduction ≥ 8 points compared to baseline NIHSS score or achievement of a NIHSS score of 0-1 at 2 hours) after 48 hours of randomization.

dichotomized functional outcome (0-2 versus 3-5) assessed by modified Rankin Scale at day 90; scale range from 0 (no deficit) to 6 (dead), a higher score means higher disability.

symptomatic intracerebral hemorrhage per the SITS-MOST definition: a local or remote Type 2 parenchymal hemorrhage on imaging 22 to 36 hours after treatment or earlier if the imaging scan was performed due to clinical deterioration combined with a neurological deterioration of 4 NIHSS points from baseline or from the lowest NIHSS score between baseline and 24 hours or leading to death within 24 hours. A grading of Type 2 parenchymal hemorrhage for intracranial hemorrhage indicates a coagulum exceeding 30% of the infarct with substantial space occupation

Wong-Baker faces pain rating scale will be administered to patient immediately after RIC and 72 hours after RIC; scale range from 0 to 10, a higher number indicate a higher pain

Feasibility will be estimated by the proportion of patients randomized to receive a RIC treatment that complete the treatment, i.e. that complete all 4 cycles (5 minutes each) of intermittent manually induced upper limb ischemia.

Whole blood hypoxia-inducible factor 1-alpha mRNA levels expressed ratio to the housekeeping gene GAPDH

Plasma heat shock protein 27 levels expressed as ng/mL

IPD will be shared in an open access directory upon completion of the project, after January 2023 and will include study protocol, statistical analysis plan, informed consent form and result dataset.

Dr. Simone Beretta

Principal Investigator, Stroke Neurologist, MD, PhD

San Gerardo Hospital

University of Milano Bicocca

Università degli Studi dell'Aquila

University of Roma La Sapienza

Istituto Di Ricerche Farmacologiche Mario Negri

Ministero della Salute, Italy

Phase II, prospective, multicenter, block randomized, parallel, open-label, clinical trial

facial pain/інфаркт

Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies

Найповніша база даних про лікарські трави, підкріплена наукою