NCT01113775

Brief Summary

This is a prospective, observational, multicenter study. The primary aim of the study is to assess the accuracy of spiral CT scan to detect right ventricular dysfunction as compared to current 'gold standard'in patients with pulmonary embolism. At the purpose of this study right ventricular dysfunction as assessed by transthoracic echocardiography and serum levels of troponin are considered as gold standard. The secondary aim of the study is to assess the prognostic value of right ventricular dysfunction as assessed by spiral CT scan.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at 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

January 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
Last Updated

May 17, 2010

Status Verified

October 1, 2009

First QC Date

April 29, 2010

Last Update Submit

May 14, 2010

Conditions

Pulmonary Embolism

Keywords

pulmonary embolismcomputed tomography

Study Arms (2)

presence of right ventricle dysfunction

absence of right ventricle dysfunction

Eligibility Criteria

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

Consecutive patients with spiral CT scan positive for acute pulmonary embolism and with transthoracic echocardiography ± 6 hours from spiral CT scan and baseline troponin levels evaluation.

You may qualify if:

  • Consecutive patients with spiral CT scan positive for acute pulmonary embolism and with transthoracic echocardiography ± 6 hours from spiral CT scan and baseline troponin levels evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal and Cardiovascular Medicine Department

Perugia, 060100, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Cecilia Becattini, MD

    University Of Perugia

    STUDY CHAIR

Central Study Contacts

Cecilia Becattini, MD

CONTACT

0039 075 578 6424cecilia.becattini@unipg.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2010

First Posted

April 30, 2010

Study Start

January 1, 2007

Last Updated

May 17, 2010

Record last verified: 2009-10

Locations

IT(1)