Acute Ischemic StrokeNCT05345366
The Correlation Between CITED2 and Collateral Circulation in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.
Trial summary
Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- non-applicable
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Mar 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were diagnosed with acute ischemic stroke in the neurology department of our hospital from November 2020 to November 2023.
Who may be able to join
- the first-time onset or previous stroke with mRS score ≤1, and the onset time less than 3 days without intravenous thrombolysis or endovascular therapy ;
- age range of 18 to 80 years old;
- patients with a clinical diagnosis of acute ischemic stroke; ④ NIHSS score ≥4; ⑤ patients volunteer to participate in this study and signed a written informed consent
Who cannot join
- ①the patients with AIS combined with other diseases that may affect the CITED2 and VEGF expression, such as acute myocardial infarction, peripheral artery occlusion disease and congenital heart defect;
- the patients exhibited serious heart, live or kidney diseases; ③disturbance of consciousness or mental illness; ④ patients with tumor; ⑤ pregnant and lactating patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of CITED2 on Collateral Circulation and Early Neurological Functional Outcome for Ischemic Stroke by Critically Regulating HIF-1α-VEGF Pathway
Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Thus, the research objective was to evaluate the predicting role of the CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the AIS patients into two groups (the good collateral group and the poor collateral group) by DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary logistic regression analysis between collateral circulation and clinical data was performed. Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the predictive value of the CITED2.
- Conditions
- Acute Ischemic Stroke
- Being tested
- non-applicable
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-applicableOther
non-applicable
| Study group | Role | What they receive |
|---|---|---|
| the good collateral group | Not described Receives: Other: non-applicable | |
| the poor collateral group | Not described Receives: Other: non-applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
CITED2
western blot/ELISA
Measured: within 24 hours after hospitalization
VEGF
western blot/ELISA
Measured: within 24 hours after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Nov 2020
- Primary completion30 Nov 2021
- Study completion1 Mar 2024
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345366
- Sponsor's protocol ID
- 2021LX0027-GC
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu M, Liu Y, Xian Z, Yu X, Chen J, Tan S, Zhang P, Guo Y. VEGF to CITED2 ratio predicts the collateral circulation of acute ischemic stroke. Front Neurol. 2022 Sep 30;13:1000992. doi: 10.3389/fneur.2022.1000992. eCollection 2022.
PubMed 36247751
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of CITED2 on Collateral Circulation and Early Neurological Functional Outcome for Ischemic Stroke by Critically Regulating HIF-1α-VEGF Pathway
- ClinicalTrials.gov ID
- NCT05345366
- Acronym / sponsor ID
- 2021LX0027-GC
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 Apr 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.
Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Thus, the research objective was to evaluate the predicting role of the CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the AIS patients into two groups (the good collateral group and the poor collateral group) by DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary logistic regression analysis between collateral circulation and clinical data was performed. Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the predictive value of the CITED2.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the good collateral group | – | Other: non-applicable |
| the poor collateral group | – | Other: non-applicable |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed with acute ischemic stroke in the neurology department of our hospital from November 2020 to November 2023.
Key inclusion criteria (3 listed)
- the first-time onset or previous stroke with mRS score ≤1, and the onset time less than 3 days without intravenous thrombolysis or endovascular therapy ;
Key exclusion criteria (2 listed)
- ①the patients with AIS combined with other diseases that may affect the CITED2 and VEGF expression, such as acute myocardial infarction, peripheral artery occlusion disease and congenital heart defect;
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 |
|---|---|---|
| non-applicablenon-applicable | Other | the good collateral group, the poor collateral group |
Primary outcome
CITED2
Time frame: within 24 hours after hospitalization
western blot/ELISA
VEGF
Time frame: within 24 hours after hospitalization
western blot/ELISA
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 6 Jun 2024.
- Derived from this study: PubMed 36247751Lu M, Liu Y, Xian Z, Yu X, Chen J, Tan S, Zhang P, Guo Y. VEGF to CITED2 ratio predicts the collateral circulation of acute ischemic stroke. Front Neurol. 2022 Sep 30;13:1000992. doi: 10.3389/fneur.2022.1000992. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Zhujiang Hospital 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 3 inclusion and 2 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 6 Jun 2024. 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?
CITED2 (time frame: within 24 hours after hospitalization). The study lists 2 primary outcomes in all. 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 NCT05345366, 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 6 Jun 2024.