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Not yet recruiting NCT06702644

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

No phase Interventional Carotid Artery Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote ischemic conditioning, Sham remote ischemic conditioning.
Who it may be relevant to
Registry conditions: Carotid Artery Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

In this study, 60 patients with internal carotid artery occlusion receiving hybird surgery are included in our center in China. The experimental group will receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group will receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.

Interventions

  • Device Remote ischemic conditioning
    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.
  • Device Sham remote ischemic conditioning
    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.

Primary outcome measures

  • Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans. [Time frame: 6 days]
Secondary outcome measures (5)
  • The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans. [Time frame: 6 days]
  • The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans. [Time frame: 6 days]
  • Number of patients with cerebrovascular events, cardiovascular events or death [Time frame: 90±7 days]
  • Proportion of patients with any side effects of RIC treatment. [Time frame: 6 days]
  • Proportion of patients with any adverse events（including serious adverse events) [Time frame: 90±7 days]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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))
  • The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
  • Pregnant or lactating women
  • He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission
  • Other conditions that the researchers think are not suitable for the group

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06702644 · SERIC-HS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗