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

NCT05614401 | Completed

• 1 other identifier: XJTU1AF2022LSK-407
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the proportion of favorable outcome (mRS scores 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

Study Arms (2)

RIPC group

Patients underwent RIPC treatment after IV thrombolysis in the index stroke.

Other: functional and medical information

Control group

The control group underwent no inflations or deflations in the index stroke.

Other: functional and medical information

Interventions

functional and medical information OTHER

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; RIPC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• An J, Wei M, Wang D, Zhao C, Yuan X, Kimberly WT, Luo G, Li G. Long-term efficacy of remote ischaemic postconditioning after rt-PA intravenous thrombolysis in patients with acute ischaemic stroke. BMJ Open. 2025 Oct 28;15(10):e094001. doi: 10.1136/bmjopen-2024-094001.

  PMID: 41151950 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Functional Status

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Guoliang Li

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: October 28, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-10

Locations

CN (1)