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

NCT06702644 | Not Yet Recruiting DMC

• 1 other identifier: SERIC-HS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carotid Artery Occlusion

Keywords

RIC; remote ischemic conditioning; carotid artery occlusion; hybird surgery; interventional surgery

Outcome Measures

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.

  6 days

Secondary Outcomes (5)

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

  6 days

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

  6 days

• Number of patients with cerebrovascular events, cardiovascular events or death

  90±7 days

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

  6 days

• Proportion of patients with any adverse events（including serious adverse events)

  90±7 days

Study Arms (2)

RIC

ACTIVE COMPARATOR

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 inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment.

Device: Remote ischemic conditioning

Sham RIC

PLACEBO COMPARATOR

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 inflation of a blood pressure cuff to 60 mmHg. Sham RIC will be conducted twice daily for 6 consecutive days after enrollment.

Device: Sham remote ischemic conditioning

Interventions

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.

RIC

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.

Sham RIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi Yang: lead

Study Officials

• Yi Yang, MD, PhD

  Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

  STUDY CHAIR

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

0086-13756661217; doctor_yangyi@163.com

Zhenni Guo, MD, PhD

CONTACT

zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president of The First Hospital of Jilin University

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share