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Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.

NCT ID: NCT02611115

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marco Das

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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15-4-167

Identifier Type: -

Identifier Source: org_study_id