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

This study has been completed.
Sponsor:
Collaborator:
Stanley Thomas Johnson Foundation, Bern, Switzerland
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01258140
First received: December 6, 2010
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  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 Blind (Subject)
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Accuracy of normal- and low-dose CTPA on composite reference standard [ Time Frame: 90 days after CTPA ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evidence of PE or deep venous thrombosis in 90 days following CTPA [ Time Frame: 90 days after CTPA ] [ Designated as safety issue: Yes ]
  • PE-related death in 90 days after CTPA [ Time Frame: 90 days after CTPA ] [ Designated as safety issue: Yes ]
  • Diagnostic confidence with normal- and low-dose CTPA [ Time Frame: 2 months after recruitment of last patient ] [ Designated as safety issue: No ]
  • Radiation dose with both CTPA protocols [ Time Frame: 2 months after recruitment of last patient ] [ Designated as safety issue: No ]

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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 6, 2010
Last Updated: January 21, 2013
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on May 19, 2013