Aortic AneurysmNCT03339414
Blood microRNA Depression Change After DHCA
An observational study of Aortic Aneurysm, run by China International Neuroscience Institution at 1 site in China.
Trial summary
Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- collect blood
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 20 Feb 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20-100
Who may be able to join
- aortic dissection patients
Who cannot join
- other organ disorder
Trial locations and contacts
1 site in 1 country.
About this study
Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point.
Read the detailed description
Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point Test the blood sample of DHCA, analysis the correlation between miR-194 and temperature.
- Conditions
- Aortic Aneurysm
- Being tested
- collect blood
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect bloodOther
collect blood at different time point
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA express change
target microRNA expression change
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Dec 2016
- Primary completion1 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaohua Wang, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339414
- Sponsor's protocol ID
- 2013-026283-1
- Status last verified
- Aug 2018
- First submitted
- 8 Nov 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood microRNA Depression Change After DHCA
- ClinicalTrials.gov ID
- NCT03339414
- Acronym / sponsor ID
- 2013-026283-1
- Conditions
- Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 13 Nov 2017 (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.
Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point.
Detailed description
Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point Test the blood sample of DHCA, analysis the correlation between miR-194 and temperature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20-100
Key inclusion criteria (1 listed)
- aortic dissection patients
Key exclusion criteria (1 listed)
- other organ disorder
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 |
|---|---|---|
| collect bloodcollect blood at different time point | Other | – |
Primary outcome
microRNA express change
Time frame: 1 day
target microRNA expression change
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 7 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Xiaohua Wang principal investigator
Xuanwu Hospital, Beijing
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 Aortic Aneurysm, run by China International Neuroscience Institution 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 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: finished, as of the sponsor's last update on 7 Aug 2018. 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?
microRNA express change (time frame: 1 day). 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 7 Aug 2018.