Aortic DissectionVaRALADNCT03780738
A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
An observational study of Aortic Dissection, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Dissection
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with aortic dissection in Guangdong Provincial People's Hospital
Who may be able to join
- Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital
Who cannot join
- Aortic dissection based on trauma, connective tissue diseases and pregnancy
- Patients with tumor
- Patients with no written consensus
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guanzhou, Guangdong, 510080
Li Xiao
About this study
The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.
- Conditions
- Aortic Dissection
- Keywords
- Aortic dissection, Aldehyde dehydrogenase 2 polymorphism
- Medical subject headings
- Aortic Dissection
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 |
|---|---|---|
| Control | Chinese Han people to do physical examination in physical examination center of Guangdong Provincial People's Hospital | |
| Aortic dissection | Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with different ALDH2 genotype
DNA was extracted from venous blood;genomic DNA underwent PCR amplification; finally, PCR products were purified and directly sequenced by Invitrogen Corp or Biosune Corp.Then ALDH2 genotype was distinguished depend on a G-to-A missense mutation on exon 12 of ALDH2 gene.
Measured: 1-30 days after samples collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780738
- Sponsor's protocol ID
- 2018GDSRMvalidation
- Acronym
- VaRALAD
- Status last verified
- Aug 2018
- First submitted
- 18 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
- ClinicalTrials.gov ID
- NCT03780738
- Acronym / sponsor ID
- VaRALAD / 2018GDSRMvalidation
- Conditions
- Aortic Dissection
- Keywords
- Aortic dissection, Aldehyde dehydrogenase 2 polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 19 Dec 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.
The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Chinese Han people to do physical examination in physical examination center of Guangdong Provincial People's Hospital |
| Aortic dissection | – | –Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with aortic dissection in Guangdong Provincial People's Hospital
Key inclusion criteria (1 listed)
- Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital
Key exclusion criteria (3 listed)
- Aortic dissection based on trauma, connective tissue diseases and pregnancy
- Patients with tumor
- Patients with no written consensus
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
Number of patients with different ALDH2 genotype
Time frame: 1-30 days after samples collected
DNA was extracted from venous blood;genomic DNA underwent PCR amplification; finally, PCR products were purified and directly sequenced by Invitrogen Corp or Biosune Corp.Then ALDH2 genotype was distinguished depend on a G-to-A missense mutation on exon 12 of ALDH2 gene.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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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.
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 Dissection, run by Qilu Hospital of Shandong 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 3 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: status not confirmed, as of the sponsor's last update on 19 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Li (+8618560088301, jfm3145496@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with different ALDH2 genotype (time frame: 1-30 days after samples collected). 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 19 Dec 2018.