NCT03616366

Brief Summary

Venous thromboembolism (VTE) is a condition which influenced by both environmental and genetic factors. This study is going to explore new significant Single nucleotide polymorphisms (SNPs) associated with VTE by Genome-Wide Association Studies (GWAS) and bioinformatics analysis. Transcriptomics and cytokine antibody array are also used to find new biomarkers of VTE's early diagnosis, severity and prognosis.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration 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

First Submitted

Initial submission to the registry

January 4, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 6, 2018

Status Verified

July 1, 2018

Enrollment Period

2.4 years

First QC Date

January 4, 2018

Last Update Submit

July 27, 2018

Conditions

VTE

Keywords

VTESNPbiomarkers

Outcome Measures

Primary Outcomes (1)

  • All cause death

    death

    6 months

Secondary Outcomes (2)

  • Venous thromboembolism (VTE) recurrence

    6months

  • chronic thromboembolism pulmonary hypertension(CTEPH)

    6 months

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute VTE patients and healthy controls

You may qualify if:

  • Chinese Han population older than 14 years old
  • Acute VTE patients diagnosed in 1 month
  • With informed consent

You may not qualify if:

  • Patients with psychosis
  • Patients with contraindications for computed tomographic pulmonary angiography (CTPA)
  • Chronic VTE
  • Recurrence of chronic VTE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute and Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum and blood cells

Central Study Contacts

Jianguo He, MD

CONTACT

80-10-88398060hejianguofw@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pulmonary Vascular Disease Center

Study Record Dates

First Submitted

January 4, 2018

First Posted

August 6, 2018

Study Start

August 10, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 6, 2018

Record last verified: 2018-07

Locations

CN(1)