NCT04118634

Brief Summary

The purpose of the study is to evaluate the value of biomarkers in the diagnosis and risk stratification of patients with suspected pulmonary embolism.

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
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

April 18, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

December 16, 2020

Status Verified

September 1, 2019

Enrollment Period

6.3 years

First QC Date

September 26, 2019

Last Update Submit

December 13, 2020

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

  • Area under the ROC curve of biomarkers for the diagnosis of PE

    The ROC curve will be built, the area under the curve will be calculated with its confidence interval.

    2 years

  • PE related death

    Number of PE related death

    7 days

Secondary Outcomes (1)

  • Symptomatic recurrent venous thromboembolic events

    2 years

Study Arms (2)

Group with PE

The criteria for confirmation of PE are: PE on spiral computed tomography (CT) proximal deep vein thrombosis on ultrasound (US) thromboembolic events objectively confirmed during the follow up

Group without PE

The criteria for exclusion of PE are: low or moderate clinical probability and D-dimer ELISA \<0.50 µg/mL or \<10xage in patients older than 50 years and negative follow up low and moderate clinical probability and negative CT and negative follow up high clinical probability and negative CT, US and follow up.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the emergency department with suspected PE

You may qualify if:

  • Patient aged ≥ 18 years that presents to an emergency department
  • With suspected PE defined as new onset of or worsening of shortness of breath or chest pain

You may not qualify if:

  • Hemodynamic instability
  • Life expectancy less than 3 months
  • Inability to the follow-up visits
  • Therapeutic anticoagulation for any indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Jie Du, PhD

    Beijing Anzhen Hospital

    STUDY DIRECTOR

Central Study Contacts

Yulin Li, PhD

CONTACT

0086-010-64456453lyllyl_1111@163.com

Study Design

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

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 8, 2019

Study Start

April 18, 2015

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

December 16, 2020

Record last verified: 2019-09

Locations

CN(1)