Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age over 40 years old;

2. Diagnosed with ischemic stroke (including TIA and cerebral infarction), with onset time of more than 1 month;

3. Culprit arteries are the large arteries of the anterior circulation with atherosclerotic stenosis (≥50%) or occlusion;

4. ASITN/SIR collateral circulation of 0-3 based on DSA evaluation;

Disqualifiers

1) Patients with severe infection or serious diseases such as liver, kidney, hematopoietic system, endocrine system, etc.;

2) Patients with a history of stroke and severe sequelae (mRS≥3);

3) arterial stenosis due to aortic dissection, moyamoya disease; Any known vasculitic disease; herpes zoster, varicella-zoster or other viral infections with vascular lesions; neurosyphilis; other intracranial infections; any intracranial artery stenosis associated with hypercytosis of cerebrospinal fluid; radiation-induced vascular lesions; myofiber dysplasia; sickle cell disease; neurofibromas; benign vascular lesions of the central nervous system; postpartum vascular disease; stenosis of the intracranial arteries due to vasospasm or thrombosm;

4) Uncontrolled severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110 mmHg after drug treatment) ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote ischemic preconditioning

    Device

    The patients in experiment group will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg) for 1 year as an adjunct to guideline-based treatment.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Remote ischemic preconditioning and guideline-based treatmentExperimental treatment 1 intervention
Group B: Guideline-based treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The proportion of collateral status improvement.

collateral status improvement is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization.

Time frame
12 months

Secondary outcomes

1

The influence of RIC to neurological functions

Neurological functions was determined by modified Rankin Scale score (0-42, higher scores mean a worse outcome )

Time frame
12 months
2

Recurrence of nonfatal ischemic stroke in 12 months

Ischemic stroke is diagnosed based on clinical symptom and neuroimaging

Time frame
12 months
3

Composite vascular events

Composite vascular events include stroke, myocardial infarction, vascular death

Time frame
12 months
4

Influence on heart function

heart function is assessed by cardiac ultrasound, electrocardiogram, myocardial enzyme profile, etc

Time frame
12 months

Other outcomes

Sponsors and contacts

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