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NCT05550103 | Recruiting | Acute Ischemic Stroke

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

Y i yang

Information provided by (Responsible Party):

Y i yang

Brief 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.

Condition or disease

Acute Ischemic Stroke

Intervention/treatment

Remote ischemic conditioning

Sham remote ischemic conditioning

Standard medical treatment

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : Quadruple
Primary Purpose : Treatment
Official Title : Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : May 1, 2023
Arm Intervention/treatment

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
  • 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.
Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)

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

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Locations

Recruiting

China, Jilin

The First Hospital of Jilin University

Changchun, Jilin, China, 130000