Subarachnoid HemorrhagemiRNANCT03344744
miRNA Profile in Aneurysmal Subarachnoid Haemorrhage
An observational study of Subarachnoid Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The investigators aim to investigate and understand the circulating miRNA profiles after acute aneurysmal subarachnoid haemorrhage and underlying pathological significance. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2017to 31 Aug 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Acute aneurysmal subarachnoid hemorrhage patients with and without delayed cerebral infarction * Healthy volunteers
Who may be able to join
- Aneurysmal subarachnoid hemorrhage patients within the first 72 hours or Healthy volunteers
Who cannot join
- Previous neurological diseases such as stroke or dementia
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Surgery, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: Circulating and CSF miRNA Profile in Patients With Acute Aneurysmal Subarachnoid Haemorrhage
The investigators aim to investigate and understand the circulating miRNA profiles after acute aneurysmal subarachnoid haemorrhage and underlying pathological significance.
Read the detailed description
- The investigators aim to investigate the miRNA classifier for delayed cerebral infarction after aneurysmal subarachnoid haemorrhage;
- The investigators aim to investigate the corresponding circulating and CSF miRNA profiles.
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Haemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
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 |
|---|---|---|
| SAH with DCI | Aneurysmal subarachnoid haemorrhage patients with delayed cerebral infarction | |
| SAH nonDCI | Aneurysmal subarachnoid haemorrhage patients without delayed cerebral infarction | |
| Control | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating micro RNA concentrations
Serum micro RNA concentrations
Measured: Day 3
Secondary outcomes (3)
Circulating micro RNA change
Changes of serum micro RNA concentrations between days 1,2,3,7
Measured: Days 1,2,3,7
Cerebrospinal fluid micro RNA concentrations
Cerebrospinal fluid micro RNA concentrations
Measured: Day 1,2,3,7
Cerebrospinal fluid micro RNA change
Changes of cerebrospinal fluid micro RNA concentrations between days 1,2,3,7
Measured: Days 1,2,3,7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start30 Nov 2017
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George KC Wong, Chinese University of Hong Kong
- Investigators
- George KC Wong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344744
- Sponsor's protocol ID
- miSAH003
- Acronym
- miRNA
- Status last verified
- Sep 2023
- First submitted
- 12 Oct 2017
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lu G, Wong MS, Xiong MZQ, Leung CK, Su XW, Zhou JY, Poon WS, Zheng VZY, Chan WY, Wong GKC. Circulating MicroRNAs in Delayed Cerebral Infarction After Aneurysmal Subarachnoid Hemorrhage. J Am Heart Assoc. 2017 Apr 25;6(4):e005363. doi: 10.1161/JAHA.116.005363.
PubMed 28442458Su XW, Chan AH, Lu G, Lin M, Sze J, Zhou JY, Poon WS, Liu Q, Zheng VZ, Wong GK. Circulating microRNA 132-3p and 324-3p Profiles in Patients after Acute Aneurysmal Subarachnoid Hemorrhage. PLoS One. 2015 Dec 16;10(12):e0144724. doi: 10.1371/journal.pone.0144724. eCollection 2015.
PubMed 26675167Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.
PubMed 22851612
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating and CSF miRNA Profile in Patients With Acute Aneurysmal Subarachnoid Haemorrhage
- ClinicalTrials.gov ID
- NCT03344744
- Acronym / sponsor ID
- miRNA / miSAH003
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 17 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.
The investigators aim to investigate and understand the circulating miRNA profiles after acute aneurysmal subarachnoid haemorrhage and underlying pathological significance.
Detailed description
- The investigators aim to investigate the miRNA classifier for delayed cerebral infarction after aneurysmal subarachnoid haemorrhage;
- The investigators aim to investigate the corresponding circulating and CSF miRNA profiles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAH with DCI | – | –Aneurysmal subarachnoid haemorrhage patients with delayed cerebral infarction |
| SAH nonDCI | – | –Aneurysmal subarachnoid haemorrhage patients without delayed cerebral infarction |
| Control | – | –Healthy volunteers |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Acute aneurysmal subarachnoid hemorrhage patients with and without delayed cerebral infarction * Healthy volunteers
Key inclusion criteria (1 listed)
- Aneurysmal subarachnoid hemorrhage patients within the first 72 hours or Healthy volunteers
Key exclusion criteria (1 listed)
- Previous neurological diseases such as stroke or dementia
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
Circulating micro RNA concentrations
Time frame: Day 3
Serum micro RNA concentrations
3 secondary outcomes
Circulating micro RNA change
Time frame: Days 1,2,3,7
Cerebrospinal fluid micro RNA concentrations
Time frame: Day 1,2,3,7
Cerebrospinal fluid micro RNA change
Time frame: Days 1,2,3,7
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 Sep 2023.
- Background: PubMed 28442458Lu G, Wong MS, Xiong MZQ, Leung CK, Su XW, Zhou JY, Poon WS, Zheng VZY, Chan WY, Wong GKC. Circulating MicroRNAs in Delayed Cerebral Infarction After Aneurysmal Subarachnoid Hemorrhage. J Am Heart Assoc. 2017 Apr 25;6(4):e005363. doi: 10.1161/JAHA.116.005363.
- Background: PubMed 26675167Su XW, Chan AH, Lu G, Lin M, Sze J, Zhou JY, Poon WS, Liu Q, Zheng VZ, Wong GK. Circulating microRNA 132-3p and 324-3p Profiles in Patients after Acute Aneurysmal Subarachnoid Hemorrhage. PLoS One. 2015 Dec 16;10(12):e0144724. doi: 10.1371/journal.pone.0144724. eCollection 2015.
- Background: PubMed 22851612Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.
- Individual participant dataSharing planned: Undecided
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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.
George KC Wong principal investigator
Chinese University of Hong Kong
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 Subarachnoid Hemorrhage, run by Chinese University of Hong Kong 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 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?
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?
Circulating micro RNA concentrations (time frame: Day 3). 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 NCT03344744, which also lists 3 linked publications.
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 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.