Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

NCT05125861 | Completed DMC

• 1 other identifier: CARIC-IVT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact of remote ischemic conditioning on dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.

Conditions

Remote Ischemic Conditioning

Keywords

Remote Ischemic Conditioning; Dynamic Cerebral Autoregulation

Outcome Measures

Primary Outcomes (1)

• Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree

  A dynamic cerebral auto-regulation parameter 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 parameters.

  1-2 days

Secondary Outcomes (4)

• Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree

  1-2 days

• Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree

  7-10 days

• Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree

  7-10 days

• Hematology related indicators

  before and 24 hours after intravenous thrombolysis

Study Arms (2)

RIC group

ACTIVE COMPARATOR

RIC+Standard medical treatment 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 mmHg. RIC will be conducted twice within 6 to 24 hours from thrombolysis.

Procedure: remote ischemic conditioning

control group

PLACEBO COMPARATOR

Sham RIC+Standard medical treatment 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 mmHg. RIC will be conducted twice twice within 6 to 24 hours from 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. All patients underwent dynamic cerebral autoregulation on days 1-2 and 7-10 after onset, and intravenous blood was collected by a nurse and stored in the laboratory 0-6 hours after thrombolysis and 24 hours after thrombolysis.

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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. All patients underwent dynamic cerebral autoregulation on days 1-2 and 7-10 after onset, and intravenous blood was collected by a nurse and stored in the laboratory 0-6 hours after thrombolysis and 24 hours after thrombolysis.

control 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 years, \< 80 years, regardless of sex;
• Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
• Baseline NIHSS \>= 5, and \<= 25;
• Baseline GCS ≥8;
• Signed and dated informed consent is obtained

You may not qualify if:

• Patients who undergo endovascular treatment;
• mRS ≥ 2 before the onset of the disease;
• Severe organ dysfunction or failure;
• Those who have a history of atrial fibrillation;
• The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
• Pregnant or lactating women;
• Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
• He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
• Other conditions that the researchers think are not suitable for the group.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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: November 1, 2021
• First Posted: November 18, 2021
• Study Start: September 1, 2018
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

CN (1)