Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYi Yang

About this trial

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years, regardless of sex

Patients with chronic carotid artery occlusion who are going to undergo hybird surgery

Can cooperate with and complete brain magnetic resonance imaging (MRI) examination

Signed and dated informed consent is obtained

Disqualifiers

Hemorrhagic stroke

Severe cardiac dysfunction or arrhythmia

Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment)

Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl))

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote ischemic conditioning

    Device

    Remote ischemic conditioning: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.

  • Sham remote ischemic conditioning

    Device

    Sham remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: RICActive comparator 1 intervention
Group B: Sham RICPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

Patients will undergo magnetic resonance imaging (including DWI) at baseline and 6 days after randomization.

Time frame
6 days

Secondary outcomes

1

The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

Patients will undergo magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.

Time frame
6 days
2

The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.

Patients will undergo magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.

Time frame
6 days
3

Number of patients with cerebrovascular events, cardiovascular events or death

Cerebrovascular events include ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events include angina and myocardial infarction. Death include all-cause of death.

Time frame
90±7 days
4

Proportion of patients with any side effects of RIC treatment.

The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications or hybrid surgery.

Time frame
6 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

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