Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-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

NCT05598658

RICCH-IVT

Details and patient eligibility

About

The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis

Full description

In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The RIC group receive basic treatment and remote ischemic conditioning for 200mmHg at 6 and 18-24 hours after intravenous thrombolysis. The sham-RIC group receive basic treatment and remote ischemic conditioning for 60mmHg at 6 and 18-24 hours after intravenous thrombolysis. Both groups underwent cerebral hemodynamics after RIC and recorded the relevant indexes. The investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age ≥ 18 and < 80 years, both sexes;
2. a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;
3. pre-onset modified Rankin Scale (mRS) score ≤1;
4. baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
5. Glasgow Coma Scale score ≥8.

Exclusion criteria

1. having received bridging therapy (IVT plus mechanical thrombectomy);
2. previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;
3. contraindications to RIC treatment or previous RIC treatment or similar treatment;
4. pregnancy or breastfeeding;
5. life expectancy of ≤3 months or inability to complete the study for other reasons;
6. unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;
7. had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

RIC group

Active Comparator group

Description:

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 mm Hg. RIC will be conducted at 6 and 18-24 hours after intravenous thrombolysis.

Treatment:

Procedure: Remote ischemic conditioning

Sham-RIC group

Placebo Comparator group

Description:

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 mm Hg. RIC will be conducted at 6 and 18-24 hours after intravenous thrombolysis.

Treatment:

Procedure: Sham remote ischemic conditioning