NCT03672123

Brief Summary

Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

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

First Submitted

Initial submission to the registry

September 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

4.8 years

First QC Date

September 5, 2018

Last Update Submit

October 26, 2023

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • hemodynamic deterioration

    Hemodynamic deterioration defined according to ESC criteria as: change in blood pressure defined as: drop in systolic arterial blood pressure \< 90 mmHg or at least 40 mmHg, lasting ≤ than 15 minutes

    assessed daily through study completion, average of 10 days

Secondary Outcomes (1)

  • Hemorrhagic complications

    assessed daily through study completion, average of 10 days

Study Arms (2)

APE with RVD

RVD (right ventricle disfunction) defined according to ESC (European Society of Cardiology) criteria

APE without RVD

RVD defined according to ESC criteria

Eligibility Criteria

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

The study will recruit 270 patients.

You may qualify if:

  • Adult patients with APE hospitalized who give written consent.

You may not qualify if:

  • lack of informed consent
  • APE with symptoms lasting above 14 days before the admission
  • acute coronary syndrome, diagnosed pulmonary hypertension
  • severe valve disease
  • sepsis
  • active malignancy
  • diagnosed mitochondrial diseases
  • chronic kidney disease at least stage 4 (KDIGO)
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw

Warsaw, 02-005, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum/plasma

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Marta Z Skowronska, MD

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

  • Piotr Pruszczyk, Prof.

    Medical University of Warsaw

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 14, 2018

Study Start

September 17, 2018

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)