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

Phase 1

• Conditions: Computed tomography of suspected pulmonary embolism; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2015-004657-40-SE
• Lead Sponsor: Region Örebro län

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified