We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Pulmonary Embolism With Low-dose CT Pulmonary Angiography (REDOPED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258140
First Posted: December 10, 2010
Last Update Posted: January 23, 2013
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:
Stanley Thomas Johnson Foundation, Bern, Switzerland
Information provided by:
University Hospital Inselspital, Berne
  Purpose

Computed tomography pulmonary angiography (CTPA) is the imaging method of choice to rule out acute pulmonary embolism based on its high sensitivity and specificity. Unfortunately, CTPA uses iodinated contrast media and can provoke contrast induced nephropathy. On the other hand, Computed tomography uses ionising radiation and is responsible for the half of the radiation exposure coming from medical sources.

Recent studies have proven that low-dose CTPA protocols using Computed tomography tube energy of 80 kVp and reduced volume of iodinated contrast media provide an increased vessel signal and good image quality at a significantly reduced patient exposure. However, there are no data on the sensitivity of low-kVp protocols.

The aim of this prospective randomized trial is to detect any difference between a normal-dose and a low-dose CTPA protocol in the diagnostic accuracy in the detection of acute pulmonary embolism (PE).


Condition Intervention
Embolism, Pulmonary Radiation: Computed tomography pulmonary angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Detection of Pulmonary Embolism With CT Pulmonary Angiography Using Reduced Contrast Medium and Radiation Dose: Comparison of 100 kVp and 80 kVp Protocols

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Evidence of Pulmonary Embolism (PE) on CT pulmonary angiography (CTPA) [ Time Frame: 1 hour after CTPA ]
  • Accuracy of normal- and low-dose CTPA on composite reference standard [ Time Frame: 90 days after CTPA ]

Secondary Outcome Measures:
  • Evidence of PE or deep venous thrombosis in 90 days following CTPA [ Time Frame: 90 days after CTPA ]
  • PE-related death in 90 days after CTPA [ Time Frame: 90 days after CTPA ]
  • Diagnostic confidence with normal- and low-dose CTPA [ Time Frame: 2 months after recruitment of last patient ]
  • Radiation dose with both CTPA protocols [ Time Frame: 2 months after recruitment of last patient ]

Enrollment: 504
Study Start Date: September 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients examined with normal-dose Computed tomography pulmonary angiography
Radiation: Computed tomography pulmonary angiography
CT pulmonary angiography using iodinated contrast agent
Active Comparator: 2
Patients examined with low-dose Computed tomography pulmonary angiography
Radiation: Computed tomography pulmonary angiography
CT pulmonary angiography using iodinated contrast agent

  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:

  • CTPA (CT pulmonary angiography) indicated based on clinical suspicion for pulmonary embolism
  • patient's body weight < 100 kg
  • informed consent form signed by patient

Exclusion Criteria:

  • contraindication to iodinated contrast media
  • pregnancy (if alternative imaging methods to exclude pulmonary embolism are available)
  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): NCT01258140


Locations
Switzerland
Institute of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Stanley Thomas Johnson Foundation, Bern, Switzerland
Investigators
Principal Investigator: Zsolt Szucs-Farkas, MD, PhD Institute of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Principal Investigator: Zsolt Szucs-Farkas, MD, PhD Hospital Centre Biel, Vogelsang 84, CH-2502 Biel/Bienne
  More Information

Responsible Party: Zsolt Szucs-Farkas, MD. PhD., Institute of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
ClinicalTrials.gov Identifier: NCT01258140     History of Changes
Other Study ID Numbers: 120/08
First Submitted: December 6, 2010
First Posted: December 10, 2010
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by University Hospital Inselspital, Berne:
CT angiography
radiation dose
contrast medium

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases