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

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Other: functional and medical information

• Registration Number: NCT05614401
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-28
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• All patients who completed the previous interventional rater-blinded controlled study were invited for the follow-up session.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	functional and medical information	The control group underwent no inflations or deflations in the index stroke.
RIPC group	functional and medical information	Patients underwent RIPC treatment after IV thrombolysis in the index stroke.

Primary Outcome Measures

Name	Time	Method
the proportion of excellent functional outcome, %	through study completion, an average of 5 year	An excellent functional outcome define as mRS= 0 and 1.

Secondary Outcome Measures

Name	Time	Method
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
the proportion of favorable outcome (mRS scores 0-2), %	through study completion, an average of 5 year	A favorable functional outcome define as mRS= 0-2.
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

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiantong University; 🇨🇳 Xi'an, Shaanxi, China