Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05614401
Acronym
RESPONTH
Enrollment
62
Registered
2022-11-14
Start date
2022-10-28
Completion date
2023-01-30
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

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.

Interventions

OTHERfunctional 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.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
the proportion of excellent functional outcome, %through study completion, an average of 5 yearAn excellent functional outcome define as mRS= 0 and 1.

Secondary

MeasureTime frameDescription
the proportion of favorable outcome (mRS scores 0-2), %through study completion, an average of 5 yearA 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
recurrent stroke/TIAFrom 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026