The OPTICA Study - The Optimised Computed Tomography Pulmonary Angiography (CTPA) in Pregnancy, Quality and Safety Study
NCT ID: NCT04179487
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
464 participants
OBSERVATIONAL
2018-05-29
2024-04-30
Brief Summary
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Detailed Description
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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".
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Patients with Suspected PE
Pregnant Patients with Suspected pulmonary embolism undergoing low dose CT pulmonary angiogram
OPTICA CTPA Protocol
Low dose CT pulmonary angiogram protocol
Interventions
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OPTICA CTPA Protocol
Low dose CT pulmonary angiogram protocol
Eligibility Criteria
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Inclusion Criteria
2. Age≥18 years
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Mater Misericordiae University Hospital
OTHER
University College Dublin
OTHER
Responsible Party
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Peter MacMahon
Professor Peter J Mac Mahon, MB BCH BAO, BMedSci, MRCPI, FFRRCSI.
Locations
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Mater Misericordiae University Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id
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