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OpenTrials
Completed

NCT Number: NCT02611115

Optimizing Protocols 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Image quality

    Time frame: one year

    Evaluation of subjective and objective image quality based on individualized CTPA protocols

Secondary outcomes

  1. Reduction of radiation dose

    Time frame: one year

    Effect of individualized tube voltage settings on radiation

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: OptIPeCT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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