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

This study has been terminated.
(Logistics failure and staff/scanner shortage)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302601
First Posted: March 14, 2006
Last Update Posted: April 18, 2016
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.
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Søren Hess, MD, Odense University Hospital
  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: 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

Resource links provided by NLM:


Further study details as provided by Søren Hess, MD, Odense University Hospital:

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

Enrollment: 15
Study Start Date: April 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
None relevant
Not relevant
Procedure: Scintigraphic interpretation
Not relevant

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Søren Hess, MD, Chief physician, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00302601     History of Changes
Other Study ID Numbers: 70
First Submitted: March 13, 2006
First Posted: March 14, 2006
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:
Embolism
Pulmonary Embolism
Sprains and Strains
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Wounds and Injuries