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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302601
Recruitment Status : Terminated (Logistics failure and staff/scanner shortage)
First Posted : March 14, 2006
Last Update Posted : April 18, 2016
University of Southern Denmark
Information provided by (Responsible Party):
Søren Hess, MD, Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Pulmonary Embolism Right Heart Strain Procedure: Scintigraphic interpretation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Acute Pulmonary Embolism 1 (APE 1) Trial: Prospective Investigation of Scintigraphic Diagnosis and Pathophysiology of Right Heart Strain
Study Start Date : April 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
None relevant
Not relevant
Procedure: Scintigraphic interpretation
Not relevant

Primary Outcome Measures :
  1. Purpose A: Specificity, sensitivity, predictive values, and observer variation for scintigraphic procedures [ Time Frame: 2006-2012 ]
  2. Purpose B: Blood concentrations of vasoactive substances, clot size on scintigram. [ Time Frame: 2006-2012 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00302601

Odense University Hospital
Odense C, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
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

Responsible Party: Søren Hess, MD, Chief physician, Odense University Hospital Identifier: NCT00302601     History of Changes
Other Study ID Numbers: 70
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Søren Hess, MD, Odense University Hospital:
Pulmonary embolism
Right heart strain
Lung scintigraphy
Pulmonary angiography

Additional relevant MeSH terms:
Pulmonary Embolism
Sprains and Strains
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Wounds and Injuries