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Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke

ConditionIschemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

A substantial body of basic and clinical research has demonstrated the protective effects of remote ischemic conditioning (RIC) in ischemic stroke. While these clinical studies support the safety of RIC, the neuroprotective benefits of RIC in acute ischemic stroke (AIS) patients lack robust evidence due to small sample sizes, heterogeneous RIC protocols, and variability in the severity of neurological deficits among study populations. Our recent multicenter randomized clinical trial, the RICAMIS study, investigated the efficacy of RIC in patients with acute moderate ischemic stroke. The results showed that RIC administered within 48 hours of onset significantly improved 90-day neurological outcomes in patients with moderate stroke severity. It is well established that anterior circulation stroke (ACS) and posterior circulation stroke (PCS) differ in multiple aspects, including anatomical structure, collateral circulation, blood supply, clinical manifestations, prognosis, ischemic tolerance time, and treatment response. For instance, compared to the anterior circulation, the posterior circulation has poorer collateral circulation, a higher proportion of stroke etiologies attributed to atherosclerosis, and longer ischemic tolerance time. Consequently, intravenous thrombolysis and endovascular therapy may offer a more extended therapeutic time window for PCS patients. A prespecified subgroup analysis of the RICAMIS study revealed that patients with PCS derived greater benefit from RIC than those with ACS. However, this finding requires further validation through prospective studies, as prior research has never specifically examined the efficacy of RIC in PCS patients.

Based on the above discussion, this study aims to investigate the efficacy and safety of RIC in patients with acute moderate PCS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Time from onset to treatment: ≤48 hours;

Posterior circulation ischemic stroke confirmed by CT or MRI, including patients who have received intravenous thrombolysis or endovascular therapy;

NIHSS score at randomization: 6-16, with an item 1a (level of consciousness) score of 0-1;

Disqualifiers

intracerebral hemorrhage or subarachnoid hemorrhage；

Uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite antihypertensive therapy)；

Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;

Intracranial tumor, arteriovenous malformation or aneurysm;

Trial design

Design model

Parallel

Treatments tested in this trial

  • remote ischemic conditioning

    Device

    The cuff of the remote ischemic conditioning device was placed on both upper arms (at the same position as blood pressure measurement) and inflated to 200 mmHg. The treatment protocol consisted of 5 cycles of 5-minute inflation followed by 5-minute deflation, performed twice daily. The treatment duration was 8-12 consecutive days.

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: controlNo intervention 0 interventions
Group B: RIC groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

proportion of excellent outcome

Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1. mRS ranges from 0-6, higher scores mean a worse outcome

Time frame
90±7 days

Secondary outcomes

1

proportion of favorable outcome

Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2. mRS ranges from 0-6, higher scores mean a worse outcome

Time frame
90±7 days
2

Distribution of modified Rankin Scale (mRS)

mRS scores range from 0 to 6. mRS ranges from 0-6, higher scores mean a worse outcome.

Time frame
90±7 days
3

change in National Institute of Health stroke scale (NIHSS)

NIHSS scores range 0-42, with higher scores indicating greater stroke severity

Time frame
24±6 hours
4

change in National Institute of Health stroke scale (NIHSS)

NIHSS scores range 0-42, with higher scores indicating greater stroke severity

Time frame
10±2 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Hospital of Shenyang Military Region

Lead sponsor

Source ClinicalTrials.gov
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