Clinical trial NCT04179487: The OPTICA Study - The Optimised Computed Tomography Pulmonary Angiography (CTPA) in Pregnancy, Quality and Safety Study
Official title: The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Pregnancy Related
Venous Thromboembolism
Keywords: pulmonary embolism
pregnancy
tomography xray computed
radiation dosage
negative predictive value
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Mater Misericordiae University Hospital
First posted: 2019-11-27
Enrollment: 464
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Patients with Suspected pulmonary embolism

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".

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Venous Thrombo-Embolism (VTE)
timeFrame: 3 months
Secondary outcomes:
measure: Maternal Effective Dose
timeFrame: 3 months
measure: Breast Radiation Dose
timeFrame: 3 months
measure: Foetal Radiation Dose
timeFrame: 3 months
measure: Signal to Noise Ratio
timeFrame: 3 months
measure: Contrast to Noise Ratio
timeFrame: 3 months
measure: Mean Pulmonary Trunk Enhancement
timeFrame: 3 months
measure: Subjective Imaging Quality Grade
timeFrame: 3 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
Study officials:
References:
citation: Gillespie C, Foley S, Rowan M, Ewins K, NiAinle F, MacMahon P. The OPTICA study (Optimised Computed Tomography Pulmonary Angiography in Pregnancy Quality and Safety study): Rationale and design of a prospective trial assessing the quality and safety of an optimised CTPA protocol in pregnancy. Thromb Res. 2019 May;177:172-179. doi: 10.1016/j.thromres.2019.03.007. Epub 2019 Mar 13.