Text Size

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

This study has suspended participant recruitment.
(Logistics failure and staff/scanner shortage)
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00302601
First received: March 13, 2006
Last updated: February 4, 2009
Last verified: February 2009
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Diagnostic
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:

U.S. FDA Resources

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  • Withdrawn consent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

Locations
Denmark
Odense University Hospital
Odense C, Denmark, DK-5000
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

ClinicalTrials.gov Identifier: NCT00302601     History of Changes
Other Study ID Numbers: 70
Study First Received: March 13, 2006
Last Updated: February 4, 2009
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
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013