NCT03780738

Brief Summary

The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

December 19, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

December 18, 2018

Last Update Submit

December 18, 2018

Conditions

Keywords

Aortic dissectionAldehyde dehydrogenase 2 polymorphism

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-30 days after samples collected

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with aortic dissection in Guangdong Provincial People's Hospital

You may qualify if:

  • Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital

You may not qualify if:

  • Aortic dissection based on trauma, connective tissue diseases and pregnancy
  • Patients with tumor
  • Patients with no written consensus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guanzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

4 ml vein blood samples were collected from aortic dissection or controls in tubes containing EDTA. The samples would be centrifuged and saved in a -80℃ ultra-low temperature refrigerator.

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 19, 2018

Study Start

October 1, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

December 19, 2018

Record last verified: 2018-08

Locations