Cerebral IschemiaNCT03607565
A New Parameter Derived From DSA to Evaluate Cerebral Perfusion
An observational study of Cerebral Ischemia, run by Xi'an No.3 Hospital at 1 site in China.
Trial summary
This observational study focus on a new parameter of cerebral perfusion derived form digital substraction angiography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Ischemia
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2018to 15 Jul 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the study population is from primary care clinic
Who may be able to join
- Cerebral ischemia
- patients undergone DSA
Who cannot join
- 1.cerebral hemorrhage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xi'an No.3 Hospital
Xi'an, Shaanxi, 710018
Nannan Han, doctor, +8615802952735, hannannan@stu.xjtu.edu.cn
About this study
Official title: The Association Between a New Parameter Derived From DSA and Outcomes in Cerebral Ischemia
This observational study focus on a new parameter of cerebral perfusion derived form digital substraction angiography.
Read the detailed description
Ischemic cerebrovascular disease is an important cause of death and disability in the world. Digital Subtraction Angiography (DSA) is the golden index for evaluating cerebral blood vessels. We introduced a new parameter derived from DSA to evaluate the perfusion to predict the outcomes in acute stroke with large vessel occlusion.
To study the possible relationship between the new parameter of cerebral perfusion derived from DSA and outcomes in cerebral ischemia（modified Rankin Scale）, we intend to retrospectively analyze the images derived from patients who undergone the DSA and follow-up outcomes（modified Rankin Scale）.
- Conditions
- Cerebral Ischemia
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| good perfusion in DSA | We introduced a new parameter derived from DSA to evaluate the perfusion in cerebral ischemia.(good perfusion) | |
| middle perfusion in DSA | We introduced a new parameter derived from DSA to evaluate the perfusion in cerebral ischemia.(middle perfusion) | |
| poor perfusion in DSA | We introduced a new parameter derived from DSA to evaluate the perfusion in cerebral ischemia.(poor perfusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the outcomes between good perfusions and poor perfusions
Results are reported as odds ratios (ORs) with 95% confidence intervals (CIs).
Measured: 3 months to 2 years
Secondary outcomes (1)
the outcomes between good perfusions and middle perfusions
Results are reported as odds ratios (ORs) with 95% confidence intervals (CIs).
Measured: 3 months to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start15 Jul 2018
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral IschemiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an No.3 Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nannan Han, doctor, Study director, department of neurology Xi'an No3 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607565
- Sponsor's protocol ID
- Hnn
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2018
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between a New Parameter Derived From DSA and Outcomes in Cerebral Ischemia
- ClinicalTrials.gov ID
- NCT03607565
- Acronym / sponsor ID
- Hnn
- Conditions
- Cerebral Ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Xi'an No.3 HospitalOther government
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Jul 2038 (estimated)
- First posted
- 31 Jul 2018 (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.
This observational study focus on a new parameter of cerebral perfusion derived form digital substraction angiography.
Detailed description
Ischemic cerebrovascular disease is an important cause of death and disability in the world. Digital Subtraction Angiography (DSA) is the golden index for evaluating cerebral blood vessels. We introduced a new parameter derived from DSA to evaluate the perfusion to predict the outcomes in acute stroke with large vessel occlusion.
To study the possible relationship between the new parameter of cerebral perfusion derived from DSA and outcomes in cerebral ischemia（modified Rankin Scale）, we intend to retrospectively analyze the images derived from patients who undergone the DSA and follow-up outcomes（modified Rankin Scale）.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| good perfusion in DSA | – | –We introduced a new parameter derived from DSA to evaluate the perfusion in cerebral ischemia.(good perfusion) |
| middle perfusion in DSA | – | –We introduced a new parameter derived from DSA to evaluate the perfusion in cerebral ischemia.(middle perfusion) |
| poor perfusion in DSA | – | –We introduced a new parameter derived from DSA to evaluate the perfusion in cerebral ischemia.(poor perfusion) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the study population is from primary care clinic
Key inclusion criteria (2 listed)
- Cerebral ischemia
- patients undergone DSA
Key exclusion criteria (1 listed)
- 1.cerebral hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the outcomes between good perfusions and poor perfusions
Time frame: 3 months to 2 years
Results are reported as odds ratios (ORs) with 95% confidence intervals (CIs).
1 secondary outcome
the outcomes between good perfusions and middle perfusions
Time frame: 3 months to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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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.
Nannan Han, doctor study director
department of neurology Xi'an No3 Hospital
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 Cerebral Ischemia, run by Xi'an No.3 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Ye, doctor (+8613519131549, chhty@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the outcomes between good perfusions and poor perfusions (time frame: 3 months to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2023.