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

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

Study Overview

• Status: Recruiting
• Conditions: Remote Ischemic Conditioning
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD,PhD; Phone Number: 0086-13756661217; Email: doctoryangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD,PhD; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Yi Yang, MD,PHD; Email: doctor_yangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral autoregulation parameter	Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.	1-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral blood flow velocity	Cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.	1-10 days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Hemodynamics; Remote Ischemic Conditioning; Intravenous Thrombolysis; Cerebral Autoregulation; Cerebral Blood Flow Velocity
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: RICCH-IVT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No