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

NCT05598658 | Completed DMC

• 1 other identifier: RICCH-IVT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Remote Ischemic Conditioning

Keywords

Remote Ischemic Conditioning; Intravenous Thrombolysis; Cerebral Hemodynamics; Cerebral Autoregulation; Cerebral Blood Flow Velocity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RIC group

ACTIVE COMPARATOR

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

Sham-RIC group

PLACEBO COMPARATOR

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

Interventions

Remote ischemic conditioning 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.

RIC group

Sham remote ischemic conditioning 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.

Sham-RIC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 and \< 80 years, both sexes;
• 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;
• pre-onset modified Rankin Scale (mRS) score ≤1;
• baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
• Glasgow Coma Scale score ≥8.

You may not qualify if:

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

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: April 1, 2023
• Primary Completion: January 12, 2024
• Study Completion: April 12, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (1)