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
  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:


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  • Withdrawn consent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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014