Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)
SRICDCA-IVT
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 26, 2022
October 1, 2022
4 months
September 19, 2022
October 25, 2022
Conditions
Outcome Measures
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.
0-7 days
Secondary Outcomes (2)
National Institute of Health stroke scale (NIHSS)
0-7 days
modified Rankin Scale (mRS)
0-90 days
Study Arms (2)
RIC+Standard medical treatment
ACTIVE COMPARATORRIC+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.
Sham RIC+Standard medical treatment
PLACEBO COMPARATORSham 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.
Interventions
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 (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.
Standard medical treatment
Eligibility Criteria
You may qualify if:
- \) Age≥18 years, regardless of sex;
- \) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase in 4.5 hours;
- \) Baseline mRs 2-5; and Premorbid mRS ≤ 1；
- \) Baseline NIHSS\>= 4, and \<= 24;
- \) Signed and dated informed consent is obtained;
You may not qualify if:
- \) Patients who have the contraindication of intravenous thrombolysis with alteplase;
- \) Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation;
- \) Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerevral blood vessels have not been detected;
- \) 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;
- \) Pregnant or lactating women;
- \) Previous remote ischemic conditioning therapy or similar treatment;
- \) 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);
- \) Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
- \) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
- \) Unwilling to be followed up or treated for poor compliance;
- \) 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;
- \) Other conditions that the researchers think are not suitable for the group.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yi Yanglead
Study Sites (1)
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associated Dean of First Hospital of Jilin University
Study Record Dates
First Submitted
September 19, 2022
First Posted
September 22, 2022
Study Start
October 1, 2022
Primary Completion
February 1, 2023
Study Completion
May 1, 2023
Last Updated
October 26, 2022
Record last verified: 2022-10