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

Remote Ischemic Conditioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598658
• Other study ID #: RICCH-IVT
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD,PhD
• Phone: 0086-13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Remote Ischemic Conditioning

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cerebral blood flow velocity	Cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.	1-10 days