Pregnancy Related, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
pulmonary embolism, pregnancy, tomography xray computed, radiation dosage, negative predictive value
Brief summary
A prospective multicentre study aiming to validate the clinical utility and safety of an optimised low-dose computed-tomography pulmonary angiogram (CTPA) protocol for suspected pulmonary embolism in pregnancy
Detailed description
The OPTICA study is the first prospective study of a low-dose CTPA protocol for the pregnant population. It will define the achievable dose, image quality and safety of this protocol and provide an evidence base upon which modern CTPA protocols can be appropriately compared to scintigraphy for this population. Pregnant women undergoing the specified low-dose CTPA protocol for suspected pulmonary embolism (PE), agreed across study sites with equivalent computed-tomography (CT) capabilities, will be included. Independent review of CTPAs by two radiology consultants, image data analysis and 3-month patient follow up will be performed. The diagnostic algorithm employs chest-x-ray and lower limb Doppler if lower limb symptoms are present, followed by CTPA in cases where advanced imaging is required. D-dimer is permitted within the diagnostic algorithm for patients recruited after implementation of the updated 2019 European Society of Cardiology guidelines for diagnosis and management of acute pulmonary embolism.
Interventions
DIAGNOSTIC_TESTOPTICA CTPA Protocol
Low dose CT pulmonary angiogram protocol
Sponsors
Mater Misericordiae University Hospital
University College Dublin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant patients with a suspected pulmonary embolism 2. Age≥18 years
Exclusion criteria
1. Age \< 18 years 2. Ultrasound proof of symptomatic proximal deep vein thrombosis 3. Contraindication to helical CT because of allergy to intravenous iodinated contrast or renal insufficiency (creatinine clearance \<30 ml/min) 4. Treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin initiated 24 h or more prior to eligibility assessment 5. Treatment with vitamin K antagonists (coumarin derivates i.e. warfarin) 6. Unable or unwilling to consent 7. Unable to part-take in follow-up 8. Life expectancy \<3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Venous Thrombo-Embolism (VTE) | 3 months | 3-month incidence of venous thromboembolism in pregnant patients in whom pulmonary embolism was excluded at baseline CT pulmonary angiogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Radiation Dose | 3 months | Breast Dose |
| Foetal Radiation Dose | 3 months | Foetal (Uterine) Dose |
| Signal to Noise Ratio | 3 months | Image Quality - Objective Variable |
| Maternal Effective Dose | 3 months | Maternal Effective Dose |
| Mean Pulmonary Trunk Enhancement | 3 months | Image Quality - Objective Variable (Hounsfield Units) |
| Subjective Imaging Quality Grade | 3 months | Subjective Imaging Quality Score: Score 1 - 5. Lowest score of 1 indicates a non diagnostic quality study. Best score of 5 indicates excellent quality / excellent opacification to the segmental pulmonary vessel level. |
| Contrast to Noise Ratio | 3 months | Image Quality - Objective Variable |
Countries
Ireland
Contacts
Primary ContactCiara Gillespie, MB BCH BAO
Backup ContactPeter MacMahon, MB BCH BAO
Outcome results
None listed