Computed tomography for ruling out pulmonary embolism using a minimal amount of contrast medium.

Minimizing contrast agent in computed tomography pulmonary angiography

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004657-40-SE

Enrollment

Registered

2016-04-27

Start date

2016-06-14

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computed tomography of suspected pulmonary embolism

Interventions

Trade Name: Omnipaque Product Name: Omnipaque Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: IOHEXOL CAS Number: 66108-95-0 Concentration unit: mg/ml milligram(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >= 40 years - Referred for computed tomography concerning thorax/chest-abdomen, or similar Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: - Referral including question of aortic dissection or aortic aneurysm. - Previous hypersensitivity to iodinized contrast agent, CT-examination planned with prophylaxis against hypersensitivity reaction or clinical request to minimize contrast agent dose. - Previous examination with iodinized contrast agent within the last 48 hours. - CT-protocol selection for clinical series not suitable for combination with study protocol. - Contrast agent dose for clinical series > 100 ml, or not suitable for combination with study protocol. - Patient weight >85 kg. - Estimated Glomerular Filtration Rate <60 ml/min. - Serum or plasma creatinine test older than 24 hours (acute referral) / older than 3 months (non-acute referral/planned examinations). - Patient requiring continous medical surveillance. - Patient requiring interpreter or inable to follow breathing instructions for examination. - Pregnant, potentially pregnant or nursing women, according to the patient. - Patient unable to perform CT-examination with arms above the head or patient without periferal venous catheter in the arm. - Thyrotoxicosis or Myastenia gravis

Design outcomes

Primary

Measure	Time frame
Main Objective: To develop and evaluate a computed tomography protocol for ruling out pulmonary embolism using a minimal amount of contrast medium.;Secondary Objective: To evaluate the image noise and vessel opacification in the reduced contrast medium dose protocol compared to standard protocol;Primary end point(s): Subjective image quality for diagnosticating or ruling out pulmonary embolism. Diagnosed pulmonary embolism.;Timepoint(s) of evaluation of this end point: The endpoints are evaluated in a separate session after LVLS, when all computed tomography acquisitions are performed.	—

Measure

Time frame

Main Objective: To develop and evaluate a computed tomography protocol for ruling out pulmonary embolism using a minimal amount of contrast medium.;Secondary Objective: To evaluate the image noise and vessel opacification in the reduced contrast medium dose protocol compared to standard protocol;Primary end point(s): Subjective image quality for diagnosticating or ruling out pulmonary embolism. Diagnosed pulmonary embolism.;Timepoint(s) of evaluation of this end point: The endpoints are evaluated in a separate session after LVLS, when all computed tomography acquisitions are performed.

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Secondary

Measure	Time frame
Secondary end point(s): Image noise. Vessel opacification.;Timepoint(s) of evaluation of this end point: The endpoints are evaluated in a separate session after LVLS, when all computed tomography acquisitions are performed.	—

Countries

Sweden

Contacts

Public ContactMats Lidén

Region Örebro län

mats.liden@regionorebrolan.se+46196020370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026