Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke

NCT04027621 | Completed DMC

• 1 other identifier: SERICT-AIS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Frequency of adverse events during hospitalization

  All adverse events until day-7 or discharge (whichever is earlier)

  7 days

• Frequency of adverse events during follow-up

  Severe adverse events through day-90 after the onset of acute ischemic stroke.

  3 months

Secondary Outcomes (2)

• National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge

  7 days

• Proportion of patients with Modified Rankin Scale (mRS) Score 0-2

  3 months

Other Outcomes (2)

• Changes of hematological indicators

  24 hours

• Changes of the function of dynamic cerebral autoregulation

  10 days

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 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.

Device: 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 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014

Device: sham remote ischemic conditioning

Interventions

remote ischemic conditioning DEVICE

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 group

sham remote ischemic conditioning DEVICE

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 mm Hg.

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;
• \) Double upper limbs or lower limbs paralysis was found in this case;
• \) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
• \) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
• \) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
• \) Severe organ dysfunction or failure;
• \) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
• \) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
• \) 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;
• \) Previous remote ischemic conditioning therapy or similar treatment;
• \) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
• \) Severe hepatic and renal dysfunction;

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

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: July 14, 2019
• First Posted: July 22, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 20, 2020
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

CN (1)