Effect of RIC on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation

Last updated: February 26, 2024
Sponsor: Yi Yang
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Treatment

Sham remote ischemic conditioning

Remote ischemic conditioning

Clinical Study ID

NCT05970653
RICCA-CSI
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age≥18 years, regardless of sex;
  • Patients with symptomatic or asymptomatic cerebral vascular stenosis (includinginternal carotid artery system and vertebrobasilar system) who are candidates forelective cerebrovascular stenting.
  • Patients or their immediate family members are able and willing to sign informedconsent.

Exclusion

Exclusion Criteria:

  • Patients with progressive stroke;
  • mRS≥ 2 points before admission;
  • Patients with other surgical treatments;
  • Patients with other serious diseases or a life expectancy of less than 3 months
  • Patients who had contraindication of remote ischemic conditioning, such as severe softtissue injury, fracture or vascular injury in the upper extremities, venous thrombosisin the acute or subacute stage of upper extremities;
  • Laboratory test indicators are unqualified: aspartate aminotransferase or alanineaminotransferase is 3 times higher than the upper limit of the normal range, bloodcreatinine > 265umol/L (>3mg/dl), platelet < 100×109/L, international normalized ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) exceed theupper limit of the normal range;
  • Pregnant or lactating women;
  • Patients who are participating in other clinical studies, or who have participated inother clinical studies within 3 months prior to enrollment;
  • Unwillingness to be followed up or poor adherence to treatment;
  • Other circumstances that the investigator considers unsuitable for enrolment.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Sham remote ischemic conditioning
Phase:
Study Start date:
August 02, 2023
Estimated Completion Date:
August 31, 2024

Study Description

In this study, 104 cases of patients with cerebrovascular stent implantation will be enrolled in the First Hospital of Jilin University, and they will be divided into the RIC group and the sham-RIC group. The RIC group received remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. The sham-RIC group received remote ischemic conditioning for 60mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. Two groups will be followed up to evaluate the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.

Connect with a study center

  • First Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Active - Recruiting

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