The OPTICA Study - The Optimised Computed Tomography Pulmonary Angiography (CTPA) in Pregnancy, Quality and Safety Study
OPTICA
The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy
1 other identifier
observational
464
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2018
CompletedFirst Submitted
Initial submission to the registry
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedDecember 2, 2019
November 1, 2019
5.5 years
November 25, 2019
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Venous Thrombo-Embolism (VTE)
3-month incidence of venous thromboembolism in pregnant patients in whom pulmonary embolism was excluded at baseline CT pulmonary angiogram.
3 months
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Pregnant Patients with Suspected PE
Pregnant Patients with Suspected pulmonary embolism undergoing low dose CT pulmonary angiogram
Interventions
Low dose CT pulmonary angiogram protocol
Eligibility Criteria
Pregnant Patients with Suspected pulmonary embolism
You may qualify if:
- Pregnant patients with a suspected pulmonary embolism
- Age≥18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College Dublinlead
- Mater Misericordiae University Hospitalcollaborator
Study Sites (1)
Mater Misericordiae University Hospital
Dublin, D07R2WY, Ireland
Related Publications (1)
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.
PMID: 30921536BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Peter J Mac Mahon, MB BCH BAO, BMedSci, MRCPI, FFRRCSI.
Study Record Dates
First Submitted
November 25, 2019
First Posted
November 27, 2019
Study Start
May 29, 2018
Primary Completion
December 1, 2023
Study Completion
April 1, 2024
Last Updated
December 2, 2019
Record last verified: 2019-11