Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (CARIC-IVT)

Yi Yang

Status: Completed

Conditions: Remote Ischemic Conditioning

Treatments: Procedure: sham remote ischemic conditioning; Procedure: remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05125861

CARIC-IVT

Details and patient eligibility

About

The purpose of this study is to determine the impact of remote ischemic conditioning on dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.

Full description

In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Both groups underwent dynamic cerebral autoregulation measurements at days 1 to 2 and 7 to 10 of onset and recorded the relevant indexes, and blood samples were collected before and 24 hours after intravenous thrombolysis, we aimed to determine the impact of remote ischemic conditioning combined with intravenous thrombolysis on dynamic cerebral autoregulation in acute ischemic stroke patients. We hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years, < 80 years, regardless of sex;
2. Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
3. Baseline NIHSS >= 5, and <= 25;
4. Baseline GCS ≥8;
5. Signed and dated informed consent is obtained

Exclusion criteria

1. Patients who undergo endovascular treatment;
2. mRS ≥ 2 before the onset of the disease;
3. Severe organ dysfunction or failure;
4. Those who have a history of atrial fibrillation;
5. 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;
6. Pregnant or lactating women;
7. Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
8. 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;
9. Other conditions that the researchers think are not suitable for the group.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

RIC group

Active Comparator group

Description:

RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice within 6 to 24 hours from thrombolysis.

Treatment:

Procedure: remote ischemic conditioning

control group

Placebo Comparator group

Description:

Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis.

Treatment:

Procedure: sham remote ischemic conditioning