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Status unknownNCT05550103SRICDCA-IVTUpdated Oct 26, 2022

Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)

An interventional study of Remote ischemic conditioning and Sham remote ischemic conditioning in Acute Ischemic Stroke, sponsored by Yi Yang. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Yi Yang · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

Read the detailed description

In this study, cases of ischemic stroke who undergo intravenous thrombolysis with alteplase within 4.5 hours from the onset are included 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. Both groups underwent dynamic cerebral autoregulation measurements at days 1,3,and 7 of onset and recorded the relevant indexes. We aimed to determine the effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

02

Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Yi Yang is the lead sponsor of 43 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1) Age≥18 years, regardless of sex;
  • 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase in 4.5 hours;
  • 3) Baseline mRs 2-5; and Premorbid mRS ≤ 1;
  • 4) Baseline NIHSS>= 4, and \<= 24;
  • 5) Signed and dated informed consent is obtained;

Exclusion criteria

Exclusion Criteria:

  • 1) Patients who have the contraindication of intravenous thrombolysis with alteplase;
  • 2) Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation;
  • 3) Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerevral blood vessels have not been detected;
  • 4) 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;
  • 5) Pregnant or lactating women;
  • 6) Previous remote ischemic conditioning therapy or similar treatment;
  • 7) Laboratory indicators are not qualified: Alanine transaminase (ALT) or glutamic-oxalacetic transaminase (AST) continued to rise more than 3 times the upper limit of normal, Serum creatinine > 265 umol/l (> 3.0 mg/dl);
  • 8) Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
  • 9) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
  • 10) Unwilling to be followed up or treated for poor compliance;
  • 11) 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;
  • 12) Other conditions that the researchers think are not suitable for the group.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    RIC+Standard medical treatment

    RIC+Standard medical treatment. 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. RIC will be conducted twice daily for 7 consecutive days from thrombolysis.

    Procedure: Remote ischemic conditioning · Other: Standard medical treatment

  • Placebo comparator
    Sham RIC+Standard medical treatment

    Sham RIC+Standard medical treatment. 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. RIC will be conducted twice daily for 7 consecutive days from thrombolysis.

    Procedure: Sham remote ischemic conditioning · Other: Standard medical treatment

Interventions

  • ProcedureRemote ischemic conditioning

    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.

  • ProcedureSham remote ischemic conditioning

    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.

  • OtherStandard medical treatment

    Standard medical treatment

06

What researchers measure

Primary outcomes

  1. Dynamic cerebral autoregulation parameter

    Dynamic cerebral auto-regulation 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 parameters.

    Time frame: 0-7 days

Secondary outcomes

  1. National Institute of Health stroke scale (NIHSS)

    National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.

    Time frame: 0-7 days

  2. modified Rankin Scale (mRS)

    modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

    Time frame: 0-90 days

07

Study locations

1 of 1 sites recruiting
  • The First Hospital of Jilin University
    Changchun, Jilin 130000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05550103
Lead sponsor
Yi Yang
Responsible party
Yi Yang (Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Sep 22, 2022
Start date
Oct 1, 2022
Primary completion
Feb 1, 2023 (estimated)
Completion
May 1, 2023 (estimated)
Last update
Oct 26, 2022

Study contacts

Yi Yang, MD, PhD
Contact
doctoryangyi@163.com
0086-13756661217
Zhenni Guo, MD, PhD
Contact
zhen1ni2@163.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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