Clinical trial NCT05614401: Long-term Outcome of RIPC After IV Thrombolysis in AIS Patients
Official title: Long-term Efficacy of Remote Ischemic Postconditioning After Rt-PA Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: The Randomized RESPONTH Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: the proportion of excellent functional outcome, %
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
measure: the proportion of favorable outcome (mRS scores 0-2), %
timeFrame: through study completion, an average of 5 year
measure: incidence rates of all-cause and cardiovascular mortality, %
timeFrame: From date of randomization until the date of death from any cause, assessed up to 100 months
measure: recurrent stroke/TIA
timeFrame: 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
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
References: