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CompletedNCT02611115OptIPeCTUpdated Oct 5, 2017

Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.

An observational study in Pulmonary Embolism, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-05.

Sponsored by Maastricht University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
235
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Embolism

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Keywords

  • Pulmonary Embolism
  • Multidetector Computed Tomography
  • Radiation Dosage
  • Contrast Media
  • Individualized Medicine
03

In context

Pulmonary Embolism

753 studies on the registry are indexed under Pulmonary Embolism; 157 are open to participants now.

This study's enrollment of 235 is below the median of 370 across 332 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Suspicion of pulmonary embolism

Exclusion criteria

Exclusion Criteria:

  • Severe allergy against Iopromide or any of the ingredients, previous severe CM reaction (according to current ESUR guidelines), renal insufficiency, pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
235 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Image quality

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

    Time frame: one year

Secondary outcomes

  1. Reduction of radiation dose

    Effect of individualized tube voltage settings on radiation

    Time frame: one year

07

Study locations

1 site
  • Maastricht University Medical Center
    Maastricht, Limburg 6202AZ, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02611115
Collaborators
Bayer
Responsible party
Marco Das (MD, PhD, Maastricht University Medical Center) — Principal investigator
First posted
Nov 20, 2015
Start date
Sep 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Oct 5, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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