Study of Diagnosis and Pathophysiology of Pulmonary Embolism (APE 1 Trial)

This study has been suspended.

( Logistics failure and staff/scanner shortage )

First Received: March 13, 2006 Last Updated: February 4, 2009 History of Changes

Sponsor:	Odense University Hospital
Collaborator:	University of Southern Denmark
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00302601

Purpose

The purpose of this study is to

investigate which method and criterion for diagnosing pulmonary embolism is the best and
determine the relationship between blood vessel constriction and clot size in patients developing heart failure

Condition	Intervention
Pulmonary Embolism Right Heart Strain	Procedure: Scintigraphic interpretation

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Safety/Efficacy Study
Official Title:	The Acute Pulmonary Embolism 1 (APE 1) Trial: Prospective Investigation of Scintigraphic Diagnosis and Pathophysiology of Right Heart Strain

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Embolism

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Purpose A: Specificity, sensitivity, predictive values, and observer variation for scintigraphic procedures
Purpose B: Blood concentrations of vasoactive substances, clot size on scintigram.

Estimated Enrollment:	500
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2009

Eligibility

Criteria

Inclusion Criteria:

Referred from clinical departments at Odense University Hospital
Referred to the Departments of Nuclear Medicine or Radiology for diagnostic evaluation of suspected pulmonary embolism
Referred for lung scintigraphy, spiral computer tomography, or pulmonary angiography

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302601

Locations

Sponsors and Collaborators

Odense University Hospital

University of Southern Denmark

Investigators

Principal Investigator:	Poul Henning Madsen, MD	Department of Nuclear Medicine, Odense University Hospital
Principal Investigator:	Soeren Hess, MD	Department of Nuclear Medicine, Odense University Hospital

More Information

No publications provided

Study ID Numbers:	70
Study First Received:	March 13, 2006
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00302601 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:

Pulmonary embolism
Right heart strain
Lung scintigraphy
Pulmonary angiography

Additional relevant MeSH terms:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 09, 2009