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Completed

NCT Number: NCT05598658

Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)

The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis

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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, China

About this study

In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The RIC group receive basic treatment and remote ischemic conditioning for 200mmHg at 6 and 18-24 hours after intravenous thrombolysis. The sham-RIC group receive basic treatment and remote ischemic conditioning for 60mmHg at 6 and 18-24 hours after intravenous thrombolysis. Both groups underwent cerebral hemodynamics after RIC and recorded the relevant indexes. The investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥ 18 and < 80 years, both sexes;
  • a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;
  • pre-onset modified Rankin Scale (mRS) score ≤1;
  • baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
  • Glasgow Coma Scale score ≥8.

Exclusion criteria

  • having received bridging therapy (IVT plus mechanical thrombectomy);
  • previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;
  • contraindications to RIC treatment or previous RIC treatment or similar treatment;
  • pregnancy or breastfeeding;
  • life expectancy of ≤3 months or inability to complete the study for other reasons;
  • unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;
  • had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.

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. Cerebral autoregulation parameter

    Time frame: 1-10 days

    Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2022
Registry last updated
Aug 19, 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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