Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis: A Multi-centered, Open-label, Blind Endpoint, Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Remote Ischemic Conditioning (RIC) treatment
- Conditions
- Not specified
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Enrollment
- 1150
- Locations
- 1
- Primary Endpoint
- Modified Rankin Scale (mRS) 0-1 at 90 days
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Remote Ischemic Conditioning + Medical Management
Patients in this group will receive Remote Ischemic Conditioning plus best medical management.
Intervention: Remote Ischemic Conditioning (RIC) treatment
Remote Ischemic Conditioning + Medical Management
Patients in this group will receive Remote Ischemic Conditioning plus best medical management.
Intervention: Medical Management
Medical Management
Patients in this group will receive best medical management alone.
Intervention: Medical Management
Outcomes
Primary Outcomes
Modified Rankin Scale (mRS) 0-1 at 90 days
Time Frame: at 90 days after randomization
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.
Secondary Outcomes
- Modified Rankin Scale (mRS) 0-2 at 90 days(at 90 days after randomization)
- Distribution of the Modified Rankin Scale (mRS) at 90 days(at 90 days after randomization)
- Early neurological deterioration within 48 hours(within 48 hours after randomization)
- Change of NIHSS scores from baseline to 12 days(at 12 days after randomization)
- Recurrence of Ischemic stroke within 90 days(within 90 days after randomization)
- Quality of life measured by Euro-QoL-5D-5L at 90 days(at 90 days after randomization)
- Death due to any cause within 90 days(within 90 days after randomization)