Detection of Pulmonary Embolism With Low-dose CT Pulmonary Angiography

NCT01258140 | Completed

• 1 other identifier: 120/08
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Embolism, Pulmonary

Keywords

CT angiography; radiation dose; contrast medium

Outcome Measures

Primary Outcomes (2)

• Evidence of Pulmonary Embolism (PE) on CT pulmonary angiography (CTPA)

  1 hour after CTPA

• Accuracy of normal- and low-dose CTPA on composite reference standard

  90 days after CTPA

Secondary Outcomes (4)

• Evidence of PE or deep venous thrombosis in 90 days following CTPA

  90 days after CTPA

• PE-related death in 90 days after CTPA

  90 days after CTPA

• Diagnostic confidence with normal- and low-dose CTPA

  2 months after recruitment of last patient

• Radiation dose with both CTPA protocols

  2 months after recruitment of last patient

Study Arms (2)

1

ACTIVE COMPARATOR

Patients examined with normal-dose Computed tomography pulmonary angiography

Radiation: Computed tomography pulmonary angiography

2

ACTIVE COMPARATOR

Patients examined with low-dose Computed tomography pulmonary angiography

Radiation: Computed tomography pulmonary angiography

Interventions

Computed tomography pulmonary angiography RADIATION

CT pulmonary angiography using iodinated contrast agent

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Stanley Thomas Johnson Foundation, Bern, Switzerland: collaborator

Study Sites (1)

Institute of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 10, 2010
• Study Start: September 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

CH (1)