Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke

NCT05915832 | Recruiting DMC

• 1 other identifier: RICCH-IS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact of remote ischemic conditioning on cerebral hemodynamics in patients with ischemic stroke.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Cerebral autoregulation at 7 days

  Difference in Cerebral autoregulation at 7 days after RIC/sham-RIC between two groups. Phase difference (PD) in degree can therefore serve as a useful tool in the evaluation of cerebral autoregulation. Continuous cerebral blood flow velocities (CBFV) in cm/s of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure (ABP) in mmHg will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Data on CBFV and ABP were processed using MATLAB using scripts developed by the research team. PD was then derived from transfer function analysis to assess the dynamic association between CBFV and ABP.

  0 - 7 days

Study Arms (2)

RIC

ACTIVE COMPARATOR

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 inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days.

Procedure: Remote ischemic conditioning

Sham RIC

PLACEBO COMPARATOR

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 inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days.

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 inflation of a blood pressure cuff to 200 mm Hg.

RIC

Sham 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 inflation of a blood pressure cuff to 60 mm Hg.

Sham RIC

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 years, \<80 years, both sex;
• Patients with a clinically definite diagnosis of acute ischemic stroke who are able to commence RIC treatment within 72 hours of stroke onset;
• Baseline National Institute of Health Stroke Scale (NIHSS) score\<25;
• Pre-onset modified Rankin Scale (mRS) score ≤ 1;
• Glasgow Coma Scale score ≥8;
• Signed and dated informed consent is obtained.

You may not qualify if:

• Patients who have undergone thrombolytic therapy or endovascular therapy;
• Inability to cooperate sufficiently to complete the cerebral autoregulation examination (e.g., due to a condition such as agitation, drowsiness, arrhythmia, insufficient bilateral temporal bone windows, etc.) during the recording;
• Presence of other intracranial lesions, such as cerebrovascular malformations, cerebral venous thrombosis, tumors, and other brain lesions;
• severe hepatic and renal dysfunction or failure;
• Patients with hematological disease, abnormal coagulation function, bleeding tendency, and platelet \<100×10\^9/L;
• Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities, arterial occlusive disease, subclavian artery stenosis ≥ 50%, or subclavian steal syndrome;
• pregnant or lactating women;
• Previous RIC treatment or similar treatment;
• Patients with a life expectancy of less than 3 months or patients who are unable to complete the study for other reasons;
• unwillingness to be followed up or poor treatment adherence;
• Individuals who are participating in other clinical studies, have participated in other clinical studies within 3 months prior to enrollment, or have participated in this research;
• Other conditions that the investigator considers inappropriate for enrollment.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yi Yang, MD,PhD

CONTACT

13756661217; doctor_yangyi@163.com

Zhenni Guo, MD,PhD

CONTACT

18186872986; zhen1ni2@163.com

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: Vice President of The First Hospital of Jilin University

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 23, 2023
• Study Start: June 25, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)