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Pulmonary Embolism: Multifunctional Assessment of Prognosis (PE-MAP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by University Of Perugia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113775
First Posted: April 30, 2010
Last Update Posted: May 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Clinical Research Unit
Information provided by:
University Of Perugia
  Purpose

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.


Condition
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Right Ventricular Dysfunction in Acute Pulmonary Embolism as Assessed by Spiral CT Scan: Comparison With Transthoracic Echocardiography and Evaluation of Prognostic Value

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

Estimated Enrollment: 400
Study Start Date: January 2007
Groups/Cohorts
presence of right ventricle dysfunction
absence of right ventricle dysfunction

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No exclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113775


Contacts
Contact: Cecilia Becattini, MD 0039 075 578 6424 cecilia.becattini@unipg.it

Locations
Italy
Internal and Cardiovascular Medicine Department Recruiting
Perugia, Italy, 060100
Contact: Cecilia Becattini, MD       cecilia.becattini@unipg.it   
Sponsors and Collaborators
University Of Perugia
Clinical Research Unit
Investigators
Study Chair: Cecilia Becattini, MD University Of Perugia
  More Information

Responsible Party: Giancarlo Agnelli, University of Perugia
ClinicalTrials.gov Identifier: NCT01113775     History of Changes
Other Study ID Numbers: CRU Unipg 02-06
First Submitted: April 29, 2010
First Posted: April 30, 2010
Last Update Posted: May 17, 2010
Last Verified: October 2009

Keywords provided by University Of Perugia:
pulmonary embolism
computed tomography

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases