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

This study is currently recruiting participants.

Verified by Odense University Hospital, April 2006

Sponsors and Collaborators:	Odense University Hospital University of Southern Denmark
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00302601

Purpose

The purpose of this study is to A) investigate which method and criterion for diagnosing pulmonary embolism is the best and B) 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

MedlinePlus related topics: Pulmonary Embolism

U.S. FDA Resources

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

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Age below 18
Contrast allergy
Pregnancy
S-Creatinine above 200 micromol/L
Metformin treatment
Fibrinolytic or surgical therapy between examinations
No informed consent
Withdrawn consent
Failed logistics (more than 24 hours between examinations)
No conclusive pulmonary angiography

Contacts and Locations

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

Contacts

Contact: Soeren Hess, MD	+ 45 22 97 91 19	hess@dadlnet.dk
Contact: Poul Henning Madsen, MD	+ 45 26 83 32 93	phmadsen@dadlnet.dk

Locations

Denmark
Odense University Hospital	Recruiting
Odense C, Denmark, DK-5000
Principal Investigator: Soeren Hess, MD
Principal Investigator: Poul Henning Madsen, MD

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

Study ID Numbers:	70
Study First Received:	March 13, 2006
Last Updated:	April 4, 2006
ClinicalTrials.gov Identifier:	NCT00302601
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

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009