Acute Ischemic StrokeRESPONTHNCT05614401
Long-term Outcome of RIPC After IV Thrombolysis in AIS Patients
An observational study of Acute Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- functional and medical information
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2022to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients who completed the previous interventional rater-blinded controlled study were invited for the follow-up session.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- functional and medical information
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional and medical informationOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| RIPC group | Patients underwent RIPC treatment after IV thrombolysis in the index stroke. Receives: Other: functional and medical information | |
| Control group | The control group underwent no inflations or deflations in the index stroke. Receives: Other: functional and medical information |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of excellent functional outcome, %
An excellent functional outcome define as mRS= 0 and 1.
Measured: through study completion, an average of 5 year
Secondary outcomes (3)
the proportion of favorable outcome (mRS scores 0-2), %
A favorable functional outcome define as mRS= 0-2.
Measured: through study completion, an average of 5 year
incidence rates of all-cause and cardiovascular mortality, %
Measured: From date of randomization until the date of death from any cause, assessed up to 100 months
recurrent stroke/TIA
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start28 Oct 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614401
- Sponsor's protocol ID
- XJTU1AF2022LSK-407
- Acronym
- RESPONTH
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41151950
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Remote Ischemic Postconditioning After Rt-PA Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: The Randomized RESPONTH Trial
- ClinicalTrials.gov ID
- NCT05614401
- Acronym / sponsor ID
- RESPONTH / XJTU1AF2022LSK-407
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC group | – | Other: functional and medical informationPatients underwent RIPC treatment after IV thrombolysis in the index stroke. |
| Control group | – | Other: functional and medical informationThe control group underwent no inflations or deflations in the index stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who completed the previous interventional rater-blinded controlled study were invited for the follow-up session.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional and medical information1) 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. | Other | Control group, RIPC group |
Primary outcome
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.
3 secondary outcomes
the proportion of favorable outcome (mRS scores 0-2), %
Time frame: through study completion, an average of 5 year
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 41151950An 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.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoliang Li principal investigator
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of excellent functional outcome, % (time frame: through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05614401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.