NCT02630212

Brief Summary

The purpose of this study is to evaluate 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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 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

December 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

December 1, 2018

Enrollment Period

4 years

First QC Date

December 7, 2015

Last Update Submit

February 1, 2019

Conditions

Aortic Dissection

Keywords

Aortic dissectionAldehyde dehydrogenase 2 polymorphismRisk factoraldehyde dehydrogenase 2

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

Secondary Outcomes (2)

  • Concentration of inflammatory factors in blood and aortic specimen

    1-30 days after samples collected

  • ALDH2 activity

    1-30 days after samples collected

Study Arms (2)

Control

Chinese Han people undergoing coronary angiography in Qilu Hospital in corresponding period whose coronary arteries narrowing less than 50 percent.

Aortic dissection

Chinese Han people diagnosed with aortic dissection in Qilu Hospital

Eligibility Criteria

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

Consecutive patients diagnosed with aortic dissection in Qilu Hospital.

You may qualify if:

  • Chinese Han people diagnosed with aortic dissection in Qilu 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)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, 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. 1 cm2 of aorta specimen were collected from patients operated on for Type A dissection, and refrigerated with liquid nitrogen.

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Design

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

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 15, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 5, 2019

Record last verified: 2018-12

Locations

CN(1)