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

NCT ID: NCT06702644

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-03-31

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.

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.

Conditions

Carotid Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RIC

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.

Group Type: ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type: 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 RIC

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.

Group Type: PLACEBO_COMPARATOR

Sham remote ischemic conditioning

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Vice president of The First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Yang, MD, PhD

Role: STUDY_CHAIR

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

Central Contacts

Yi Yang, MD, PhD

Role: CONTACT

doctor_yangyi@163.com

0086-13756661217

Zhenni Guo, MD, PhD

Role: CONTACT

zhen1ni2@163.com

Other Identifiers

SERIC-HS

Identifier Type: -

Identifier Source: org_study_id