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

NCT ID: NCT05598658

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-04-12

Brief Summary

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

Detailed 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.

Conditions

Remote Ischemic Conditioning

Study Design

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

Study Groups

RIC group

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.

Group Type: ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type: PROCEDURE

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg.

Sham-RIC group

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.

Group Type: PLACEBO_COMPARATOR

Sham remote ischemic conditioning

Intervention Type: PROCEDURE

Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg.

Interventions

Remote ischemic conditioning

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg.

Intervention Type: PROCEDURE

Sham remote ischemic conditioning

Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

RICCH-IVT

Identifier Type: -

Identifier Source: org_study_id