A Registry Study on Biomarkers of Pulmonary Embolism

NCT ID: NCT04118634

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-18

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Management of patients with acute pulmonary embolism is a serious problem. The rapid and accurate diagnosis and risk stratification of these patients is an important unmet clinical need. The aim of the study is to evaluate the value of biomarkers, alone or in combination, in the diagnosis and risk stratification of patients with suspected pulmonary embolism presenting to the emergency department.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Hemodynamic instability
* Life expectancy less than 3 months
* First symptoms 15 day or more before inclusion
* Inability to the follow-up visits
* Therapeutic anticoagulation for any indication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Institute of Heart, Lung and Blood Vessel Diseases

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jie Du, PhD

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yulin Li, PhD

Role: CONTACT

Phone: 0086-010-64456453

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yulin Li, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PE2019

Identifier Type: -

Identifier Source: org_study_id