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Completed

NCT Number: NCT04027621

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) Age≥18 years, < 80 years, regardless of sex;
  • 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
  • 3) Baseline NIHSS >= 5, and <= 25;
  • 4) Baseline GCS ≥8;
  • 5) Signed and dated informed consent is obtained

Exclusion criteria

  • 1) Patients who undergo endovascular treatment;
  • 2) mRS ≥ 2 before the onset of the disease;
  • 3) Double upper limbs or lower limbs paralysis was found in this case;
  • 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
  • 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
  • 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
  • 7) Severe organ dysfunction or failure;
  • 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
  • 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
  • 10) Those who have a history of atrial fibrillation;
  • 11) 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;
  • 12) Pregnant or lactating women;
  • 13) Previous remote ischemic conditioning therapy or similar treatment;
  • 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
  • 15) Severe hepatic and renal dysfunction;
  • 16) Unwilling to be followed up or treated for poor compliance;
  • 17) 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;
  • 18) Other conditions that the researchers think are not suitable for the group.

Treatment and study plan

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.

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.

Primary outcomes

  1. Frequency of adverse events during hospitalization

    Time frame: 7 days

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

  2. Frequency of adverse events during follow-up

    Time frame: 3 months

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

Secondary outcomes

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

    Time frame: 7 days

    National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.

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

    Time frame: 3 months

    Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.

Other outcomes

  1. Changes of hematological indicators

    Time frame: 24 hours

    Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.

  2. Changes of the function of dynamic cerebral autoregulation

    Time frame: 10 days

    The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Acronym: SERICT-AIS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2019
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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