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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: functional and medical information

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xian Jiantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Between August 2017 and June 2018, a total of 68 AIS patients who underwent IVT treatment were randomized into either the RIPC treatment group or the control group. During the trial period, thirty-four participants in the control group and thirty-two participants in the RIPC group were followed for the percentage of patients at 90 days with a favorable outcome, which was de- fined as a score of 0 or 1 on the modified Rankin Score (mRS). After the completion of the trial, the trial participants were followed by their primary care physicians.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RIPC group; Patients underwent RIPC treatment after IV thrombolysis in the index stroke.	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.
Control group; The control group underwent no inflations or deflations in the index stroke.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2022
• Primary Completion (ACTUAL): December 30, 2022
• Study Completion (ACTUAL): January 30, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (ACTUAL): November 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: XJTU1AF2022LSK-407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No