NCT02843243

Brief Summary

A risk stratification in hemodynamically stable patients with acute pulmonary embolism (PE) is deemed necessary to guide patient management. With the aim to improve the positive predictive value (PPV) for PE-related adverse events in in normotensive patients, a number of scores combining multiple risk-factors have been published. In addition, an algorithm for the risk-stratification of patients with PE has been proposed by the European society of cardiology. None but one of these scores underwent external and prospective validation. The aim of this study is to externally and prospectively validate the PPV for PE-related adverse events of the Bova score and modified FAST score in a large multicenter cohort.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

July 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

July 21, 2016

Last Update Submit

July 20, 2021

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Adverse events PE-related

    within 30 days from the hospital admission

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients aged 18 years or older with Pulmonary Embolism and hemodynamic stability (that is, SBP 90 mm Hg or more)

You may qualify if:

  • Pulmonary Embolism with hemodynamic stability (that is, SBP 90 mm Hg or more)

You may not qualify if:

  • Refuse of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda ospedaliera Cosenza

Cosenza, 87100, Italy

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Carlo Bova, MD

    Azienda Ospedaliera Cosenza

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 25, 2016

Study Start

December 1, 2016

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Locations

IT(1)