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Table 1. The inclusion and exclusion criteria.
Inclusion criteria
* Age ⩾ 18 years, male or female.
* Patients diagnosed with acute ischemic stroke who have received intravenous thrombolysis with alteplase within 4.5 h from
the onset.
* Pre-thrombolysis NIHSS of ⩾4 and ⩽24.
* Premorbid mRS score of 0 or 1.
* Patients or their legal representatives signed the informed consent.
Exclusion criteria
* Patients with the contraindication of intravenous thrombolysis.
* Any contraindications for remote ischemic conditioning, such as severe soft tissue injury, fracture, subclavian steal syndrome,
or peripheral vascular disease in the upper limbs.
* Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, and so on.
* Pregnant or breastfeeding women.
* Severe hepatic and renal dysfunction.
* Patients with a life expectancy of fewer than 3 months.
* Unwilling to be followed up or poor compliance to follow-up treatments.
* The patient is participating in other clinical trials within 3 months.
* Other conditions that the researchers think the subject would be unsuitable for this study.
NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin Scale.
IVT, which leads to early neurologic deterioration and poor
functional outcomes.8 In addition, due to the risk of ICH,
guidelines recommend against using antithrombotic therapy
within 24 h after IVT.2 Furthermore, neuroprotective agents
seem to have no benefits for AIS patients. Therefore, developing
a safe and effective treatment that incorporates IVT to
improve functional outcomes is crucial.
Studies have proposed that remote ischemic conditioning
(RIC) could be an adjuvant treatment for patients with
AIS who underwent IVT.9-12 RIC is a transient, repeated
ischemia/reperfusion training that protects ischemia-sensitive
target organs from ischemia.13 RIC has been indicated
to exert neuroprotective effects in experimental stroke.14-16
The underlying neuroprotective mechanism triggered by
RIC induces gene expression, alters pathways, promotes
neurogenesis and blood vessel development, reduces oxidative
stress and neuronal apoptosis, and inhibits proinflammatory
signals in the ischemic brain.17 Previously,
several clinical trials have shown that single or repeated
RIC treatments for cerebrovascular diseases are feasible
and safe.9,18,19 However, recent studies on RIC for AIS have
produced inconsistent conclusions.20-23 Hence, the efficacy
and safety of RIC remain unclear.
Therefore, we designed a multicenter, large sample, randomized
controlled trial to assess the efficacy and safety of
RIC combined with IVT for the treatment of AIS.
Methods
Design
This SERIC-IVT study (ClinicalTrials.gov Identifier:
NCT04980625) is a prospective, multicenter, randomized,
parallel-controlled, and blinded endpoint clinical trial that
is being performed in 18 hospitals in Jilin Province,
Northeast China (Supplementary Table 1). All centers are
qualified for IVT and selected from the Jilin Province
Stroke Emergency Maps (JSEM).24
The study design was approved by the Ethics Committee
of the First Hospital of Jilin University. The ethics committee
of each center approved this study. The trial will be conducted
in compliance with the International Conference on
Harmonization Good Clinical Practice guidelines (ICHGCP)
and the Declaration of Helsinki (revised 2013).
Patient population
A total of 558 patients (279 per group) with AIS who
received IVT with alteplase within 4.5 h from onset are eligible
for this study. The inclusion and exclusion criteria are
detailed in Table 1. Written informed consent will be
obtained from all participants or their legal representatives.
Randomization
Randomization will be performed by the statistician and
stratified by center, with blocks of varying sizes (4, 6, or 8).
According to the computer-generated randomization schedule,
patients will be randomized 1:1 to the RIC or shamRIC
group. The allocation sequence will be created and
stored in opaque envelopes.
Once written informed consent is obtained, on-call physicians
who are not involved in data analysis or clinical assessments
will number the participants and open the corresponding
envelope. Treatment allocation will be determined based on
International Journal of Stroke, 18(3)

http://www.ClinicalTrials.gov

WSO - March 2023

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