Large Artery Atherosclerosis is one of the most prevalent causes of stroke worldwide and is associated with a high risk of disability and recurrent strokes. Remote Ischemic Conditioning (RIC) is a promising therapy, and it has been recommended for further investigation in patients with acute ischemic stroke resulting from large artery atherosclerosis. The primary objective of this study is to assess the efficacy of RIC in patients suffering from acute moderate ischemic stroke due to large artery atherosclerosis.
This multi-centered, open-label, blind endpoint, randomized controlled trial aims to investigate the efficacy of RIC in patients with acute moderate ischemic stroke due to large artery atherosclerosis. A total of 1150 participants (age 18 to 85 years) within 48 hours of symptom onset of acute moderate ischemic stroke (NIHSS score 6-16, or NIHSS score 4-5 with disabling deficits) due to large artery atherosclerosis will be enrolled. Eligible patients will be randomized in a 1:1 ratio into RIC treatment plus medical management versus medical management alone after offering informed consent. The primary endpoint is excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1, which will be evaluated by independent researchers in the blind state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,150
RIC will be given twice a day for 10-14 days. RIC will be applied using an automated RIC device. The cuff of the RIC medical device will be placed around the bilateral upper limbs. Five cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes) for a total procedure time of 50 minutes.
Patients will receive standard guideline-directed medical therapy, which will include monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic therapy if appropriate.
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGModified Rankin Scale (mRS) 0-1 at 90 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of patients who have suffered from a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead.
Time frame: at 90 days after randomization
Modified Rankin Scale (mRS) 0-2 at 90 days
Time frame: at 90 days after randomization
Distribution of the Modified Rankin Scale (mRS) at 90 days
Time frame: at 90 days after randomization
Early neurological deterioration within 48 hours
Time frame: within 48 hours after randomization
Change of NIHSS scores from baseline to 12 days
Time frame: at 12 days after randomization
Recurrence of Ischemic stroke within 90 days
Time frame: within 90 days after randomization
Quality of life measured by Euro-QoL-5D-5L at 90 days
Time frame: at 90 days after randomization
Death due to any cause within 90 days
Time frame: within 90 days after randomization
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