The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy
Overview
- Phase
- Not Applicable
- Sponsor
- University College Dublin
- Enrollment
- 464
- Locations
- 1
- Primary Endpoint
- Incidence of Venous Thrombo-Embolism (VTE)
Overview
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".
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant patients with a suspected pulmonary embolism
- •Age≥18 years
Exclusion Criteria
- •Age \< 18 years
- •Ultrasound proof of symptomatic proximal deep vein thrombosis
- •Contraindication to helical CT because of allergy to intravenous iodinated contrast or renal insufficiency (creatinine clearance \<30 ml/min)
- •Treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin initiated 24 h or more prior to eligibility assessment
- •Treatment with vitamin K antagonists (coumarin derivates i.e. warfarin)
- •Unable or unwilling to consent
- •Unable to part-take in follow-up
- •Life expectancy \<3 months
Outcomes
Primary Outcomes
Incidence of Venous Thrombo-Embolism (VTE)
Time Frame: 3 months
3-month incidence of venous thromboembolism in pregnant patients in whom pulmonary embolism was excluded at baseline CT pulmonary angiogram.
Secondary Outcomes
- Maternal Effective Dose(3 months)
- Breast Radiation Dose(3 months)
- Foetal Radiation Dose(3 months)
- Signal to Noise Ratio(3 months)
- Contrast to Noise Ratio(3 months)
- Mean Pulmonary Trunk Enhancement(3 months)
- Subjective Imaging Quality Grade(3 months)
Investigators
Peter MacMahon
Professor Peter J Mac Mahon, MB BCH BAO, BMedSci, MRCPI, FFRRCSI.
Mater Misericordiae University Hospital