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Completed

NCT Number: NCT05614401

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

functional and medical information

Other
  • 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.

Primary outcomes

  1. the proportion of excellent functional outcome, %

    Time frame: through study completion, an average of 5 year

    An excellent functional outcome define as mRS= 0 and 1.

Secondary outcomes

  1. the proportion of favorable outcome (mRS scores 0-2), %

    Time frame: through study completion, an average of 5 year

    A favorable functional outcome define as mRS= 0-2.

  2. incidence rates of all-cause and cardiovascular mortality, %

    Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months

  3. recurrent stroke/TIA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: RESPONTH

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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