Long-term Outcome of RIPC After IV Thrombolysis in AIS Patients

Study Overview
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Brief Summary
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The goal of this observational study is to learn about the long-term efficacy of our previous study in acute ischemic stroke(AIS) patients who underwent either remote ischemic postconditioning(RIPC) or sham treatment after intravenous thrombolysis. The main questions it aims to answer are: Dose the RIPC treatment combined with IV thrombolysis can improve the long-term functional outcome in AIS patients? Dose the RIPC treatment combined with IV thrombolysis can improve the incidence rates of all-cause and cardiovascular mortality, recurrent stroke/TIA, new-onset clinical AF on this long-term follow-up? A single rater (A.E.P.) trained by an experienced stroke physician (S.T.E.) contacted patients, relatives, and family physicians to gather all available medical information on the following issues: 1) survival status, 2) date of death in those who died (based on information of the treating physicians), 3) mRS score at the time of the interview, 4) recurrent stroke/TIA, 5) new onset atrial fibrillation, 6) other cardiovascular events, including myocardial infarction, pulmonary embolism, deep venous thrombosis, peripheral arteriopathy. Researchers will compare RIPC group and control group to see if the RIPC treatment have a long-term effect in AIS patients.

Official Title
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Long-term Efficacy of Remote Ischemic Postconditioning After Rt-PA Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: The Randomized RESPONTH Trial

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Other: functional and medical information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who completed the previous interventional rater-blinded controlled study were invited for the follow-up session.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RIPC group<br>Patients underwent RIPC treatment after IV thrombolysis in the index stroke. | Other: functional and medical information<br>* 1) functional outcomes(mRS scoring), 2)survival status, 3) date of death in those who died (based on information of the treating physicians), 3) mRS score at the time of the interview, 4) recurrent stroke/TIA, 5) new onset atrial fibrillation, 6) other cardiovascular events, including myocardial infarction, pulmonary embolism, deep venous thrombosis, peripheral arteriopathy.<br>|
| Control group<br>The control group underwent no inflations or deflations in the index stroke. | Other: functional and medical information<br>* 1) functional outcomes(mRS scoring), 2)survival status, 3) date of death in those who died (based on information of the treating physicians), 3) mRS score at the time of the interview, 4) recurrent stroke/TIA, 5) new onset atrial fibrillation, 6) other cardiovascular events, including myocardial infarction, pulmonary embolism, deep venous thrombosis, peripheral arteriopathy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of excellent functional outcome, % | An excellent functional outcome define as mRS= 0 and 1. | through study completion, an average of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of favorable outcome (mRS scores 0-2), % | A favorable functional outcome define as mRS= 0-2. | through study completion, an average of 5 year | 
| incidence rates of all-cause and cardiovascular mortality, % |  | From date of randomization until the date of death from any cause, assessed up to 100 months | 
| recurrent stroke/TIA |  | From date of randomization until the date of first documented recurrent stroke/TIA or date of death from any cause, whichever came first, assessed up to 100 months |