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Completed

NCT Number: NCT04980625

Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for 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 and older

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, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. 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, regardless of sex;
  • 2) Patients with a clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase;
  • 3) Pre-thrombolysis NIHSS >= 4, and <= 24;
  • 4) Premorbid mRS 0-1;
  • 5) Signed and dated informed consent is obtained;

Exclusion criteria

  • 1) Patients who have the contraindication of intravenous thrombolysis with alteplase.
  • 2) 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.
  • 3) Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
  • 4) Pregnant or lactating women.
  • 5) Severe hepatic and renal dysfunction.
  • 6) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
  • 7) Unwilling to be followed up or treated for poor compliance.
  • 8) 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.
  • 9) Other conditions that the researchers think are not suitable for the group.

Treatment and study plan

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 inflations of a blood pressure cuff to 200 mm Hg.

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 reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg.

Primary outcomes

  1. Proportion of patients with Modified Rankin Scale (mRS) Score 0-1

    Time frame: 3 months

    Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.

Secondary outcomes

  1. National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT.

    Time frame: 24 hours, 7 days

    National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT. Ranged from 0 to 42, a low value represents a better outcome.

  2. Barthel Index (BI) at 24 hours, and 7 days after IVT.

    Time frame: 24 hours, 7 days

    Barthel Index (BI) at 24 hours, and 7 days after IVT. Ranged from 0 to 100, a high value represents a better outcome.

  3. Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT.

    Time frame: 90±3 days

    Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT. mRS: Ranged from 0 to 6, a low value represents a better outcome.

  4. Frequency of adverse events during follow-up

    Time frame: 90 days

    All adverse events through 90 days.

  5. Frequency of Hemorrhagic transformation within 24 hours after IVT.

    Time frame: 24 hours

    Frequency of Hemorrhagic transformation within 24 hours after IVT.

  6. Mortality within 90 days.

    Time frame: 90 days

    Mortality within 90 days.

  7. Stroke recurrence rate within 90 days.

    Time frame: 90 days

    Stroke recurrence rate within 90 days.

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Official study title

Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2021
Registry last updated
May 14, 2024

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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