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NCT Number: NCT04977869

Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.

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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, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are included in 10 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 for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1) Age ≥ 18 years, male or female
  • 2) Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)
  • 3) Pre-EVT NIHSS ≥ 6
  • 4) Premorbid mRS ≤ 2
  • 5) Written informed consent obtained from the patient or legally responsible person

Exclusion criteria

  • 1) Contraindication of endovascular thrombectomy
  • 2) Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
  • 3) Head CT showing cerebral hernia and midline displacement
  • 4) Pregnancy or lactation
  • 5) Previous remote ischemic conditioning therapy or similar treatment
  • 6) Severe hepatic and renal dysfunction
  • 7) Life expectancy of less than 3 months or inability to complete the study for other reasons
  • 8) Unwilling to be followed up or poor compliance
  • 9) Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
  • 10) Other conditions that the researchers think make the patient unsuitable for the study

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT.

    Time frame: 24 hours, 7 days (or discharge)

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

  2. Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT.

    Time frame: 24 hours, 7 days (or discharge)

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

  3. Proportion of patients with modified Rankin Scale (mRS) 0-1

    Time frame: 90±3 days

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

  4. modified Rankin Scale (mRS) score distribution

    Time frame: 90±3 days

    modified Rankin Scale (mRS) score distribution

  5. Recanalization rate within 7 days after EVT

    Time frame: 7 days

    Recanalization rate within 7 days after EVT

  6. Early neurological deterioration at 7 days

    Time frame: 7 days

    Early neurological deterioration at 7 days

  7. Frequency of Hemorrhagic transformation within 7 days

    Time frame: 7 days

    Frequency of Hemorrhagic transformation within 7 days

  8. Frequency of symptomatic intracranial hemorrhage within 7 days

    Time frame: 7 days

    Frequency of symptomatic intracranial hemorrhage within 7 days

  9. Death within 90 days

    Time frame: 90±3 days

    Death within 90 days

  10. Frequency of adverse events within 90 days

    Time frame: 90±3 days

    Frequency of adverse events within 90 days

  11. Adverse events associated with remote ischemic conditioning within 90 days

    Time frame: 90±3 days

    Adverse events associated with remote ischemic conditioning within 90 days

  12. Frequency of serious adverse events within 90 days

    Time frame: 90±3 days

    Frequency of serious adverse events within 90 days

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Official study title

Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2021
Registry last updated
Dec 16, 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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