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

Yi Yang

Status: Not yet enrolling

Conditions: Carotid Artery Occlusion

Treatments: Device: Remote ischemic conditioning; Device: Sham remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06702644

SERIC-HS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

RIC

Active Comparator group

Description:

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.

Treatment:

Device: Remote ischemic conditioning

Sham RIC

Placebo Comparator group

Description:

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.

Treatment:

Device: Sham remote ischemic conditioning