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

Acute Ischemic Stroke Clinical Trial

— RESPONTH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614401
• Other study ID #: XJTU1AF2022LSK-407
• Status: Completed
• Start date: October 28, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Ischemic Stroke

Intervention

Other:
• functional and medical information
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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