NCT02214043

Brief Summary

There are no special clinical characteristics of acute pulmonary embolism in Chinese population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 30, 2018

Status Verified

July 1, 2016

Enrollment Period

5.9 years

First QC Date

February 3, 2014

Last Update Submit

January 28, 2018

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE.

    60 months

Secondary Outcomes (1)

  • The second end point was death (all cause death and PE-related death).

    60 months

Study Arms (2)

Group 2

group 1

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute pulmonary embolism in Chinese population

You may qualify if:

  • the symptomatic acute PE confirmed by objective examination

You may not qualify if:

  • congestive heart failure
  • chronic obstructive pulmonary disease;
  • a prior documented episode of PE or DVT
  • renal dysfunction;
  • a life expectancy of less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of pumonary vascular diseases

Beijing, 100037, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

BNP，D-dimer

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Zhihong Liu, Doctor

    Chinese pulmonary vascular disease organization group

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

August 12, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 30, 2018

Record last verified: 2016-07

Locations

CN(1)