Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT02611115
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image quality	one year	Evaluation of subjective and objective image quality based on individualized CTPA protocols

Secondary Outcome Measures

Name	Time	Method
Reduction of radiation dose	one year	Effect of individualized tube voltage settings on radiation

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands