Effect of Remote Ischemic Preconditioning on Early Neurological Deterioration in Acute Perforating Artery Infarction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
This study aims to conduct a prospective, randomized, double-blind, multicenter, parallel-controlled, group-sequential trialto scientifically evaluate the safety and efficacy of remote ischemic preconditioning (RIC) in preventing early neurological deterioration (END) in patients with acute perforating artery infarction (PAI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older;
Diagnosed with acute ischemic stroke;
Clinical symptoms consistent with perforating artery infarction (NIHSS score ≤5, with consciousness item 1a ≤1);
Time from onset to randomization within 48 hours;
Disqualifiers
Received intravenous thrombolysis or endovascular treatment prior to randomization;
Secondary stroke caused by brain tumor, traumatic brain injury, hematologic disorders, or other conditions;
History of intracranial hemorrhage;
Presence of RIC contraindications, such as severe upper limb soft tissue injury, fracture, subclavian artery stenosis, or peripheral vascular disease;
Trial design
Design model
Parallel
Treatments tested in this trial
remote ischemic preconditioning
DeviceThe standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg.
sham remote ischemic preconditioning
DeviceThe standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg.
Treatment groups
910 Participants
are divided into 2 treatment groupsGroup A: RIC groupExperimental treatment 1 intervention
Group B: shame RIC groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of early neurological deterioration
an increase of ≥2 points in the National Institutes of Health Stroke Scale (NIHSS), including an increase of ≥1 point in the motor score. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Time frame
5 days after randomizationSecondary outcomes
1
The incidence of early neurological deterioration
an increase of ≥2 points in the National Institutes of Health Stroke Scale (NIHSS), including an increase of ≥1 point in the motor score. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Time frame
2 days after randomization2
Proportion of patients with a modified Rankin Scale score of 0-1
modified Ranking score: ranging from 0 to 6, with higher values indicating a worse functional outcome.
Time frame
90 days after randomization3
The incidence of early neurological improvement
defined as a decrease of ≥2 points in National Institutes of Health Stroke Scale (NIHSSS). NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Time frame
5 days after randomization4
The incidence of early neurological improvement
defined as a decrease of ≥2 points in National Institutes of Health Stroke Scale (NIHSS). NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Time frame
2 days after randomizationOther outcomes
1
The incidence of adverse events related to RIC
Clinical safety endpoint
Time frame
within 90 days from randomization2
The incidence of mortality
Clinical safety endpoint
Time frame
within 90 days from randomization3
The incidence of adverse events
Clinical safety endpoint
Time frame
within 90 days from randomization4
The incidence of severe adverse events
Clinical safety endpoint
Time frame
within 90 days from randomizationSponsors and contacts
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Source ClinicalTrials.gov