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NCT Number: NCT06702644

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 6 days

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

Secondary outcomes

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

    Time frame: 6 days

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

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

    Time frame: 6 days

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

  3. Number of patients with cerebrovascular events, cardiovascular events or death

    Time frame: 90±7 days

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

  4. Proportion of patients with any side effects of RIC treatment.

    Time frame: 6 days

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

  5. Proportion of patients with any adverse events(including serious adverse events)

    Time frame: 90±7 days

    Adverse events due to any cause after enrollment of subjects in both groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yang, MD, PhD

CONTACT

[email protected]

0086-13756661217

Zhenni Guo, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Acronym: SERIC-HS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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