Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography. (OptIPeCT)

October 4, 2017 updated by: Marco Das, Maastricht University Medical Center

Optimizing Tube Voltage Settings and Injection Parameters for the Individual Patient in CT Pulmonary Angiography.

Computed tomographic pulmonary angiography (CTPA) is considered the gold standard for the diagnosis of pulmonary embolism (PE). PE is a potentially fatal disease in which a thrombus is lodged into a pulmonary artery blocking blood flow and potentially leading to respiratory distress, acute right cardiac failure or death. Therefore early and correct diagnosis is crucial.

The diagnostic and clinical value of CTPA has already been firmly substantiated. Unfortunately up to 7.3% of PE scans are still deemed to be non-diagnostic, for example due to insufficient contrast enhancement in the target arteries.

Therefore future research should focus on two important aspects of CT imaging. On the one hand optimal enhancement for the individual patient, on the other hand preventing additional risk of CT imaging - namely contrast induced nephropathy (CIN) and radiation risk. Thus the purpose of our study will be to optimize radiation dose settings (e.g. tube voltage, tube current) and CM application for the individual patient in CTPA.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202AZ
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients referred for CTPA with a clinical suspicion of pulmonary embolism will be included.

Description

Inclusion Criteria:

  • Suspicion of pulmonary embolism

Exclusion Criteria:

  • Severe allergy against Iopromide or any of the ingredients, previous severe CM reaction (according to current ESUR guidelines), renal insufficiency, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality
Time Frame: one year
Evaluation of subjective and objective image quality based on individualized CTPA protocols
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of radiation dose
Time Frame: one year
Effect of individualized tube voltage settings on radiation
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-4-167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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