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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University Of Perugia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Clinical Research Unit
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT01113775
First received: April 29, 2010
Last updated: May 14, 2010
Last verified: October 2009
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Giancarlo Agnelli, University of Perugia
ClinicalTrials.gov Identifier: NCT01113775     History of Changes
Other Study ID Numbers: CRU Unipg 02-06
Study First Received: April 29, 2010
Last Updated: May 14, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by University Of Perugia:
pulmonary embolism
computed tomography

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Ventricular Dysfunction, Right
Ventricular Dysfunction
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases

ClinicalTrials.gov processed this record on June 18, 2013