The OPTICA Study - The Optimised Computed Tomography Pulmonary Angiography (CTPA) in Pregnancy, Quality and Safety Study

Pregnancy Related Clinical Trial

— OPTICA  

Official title:

The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179487
• Other study ID #: 01
• Status: Recruiting
• Start date: May 29, 2018
• Est. completion date: April 2024

Study information

• Verified date: November 2019
• Source: University College Dublin
• Contact: Ciara Gillespie, MB BCH BAO
• Phone: +353 1 8032000
• Email: ciaragillespie[@]mater.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 464
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pregnancy Related
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Diagnostic Test:
• OPTICA CTPA Protocol
Low dose CT pulmonary angiogram protocol

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	Mater Misericordiae University Hospital

Country where clinical trial is conducted

Ireland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal Effective Dose	Maternal Effective Dose	3 months
Secondary	Breast Radiation Dose	Breast Dose	3 months
Secondary	Foetal Radiation Dose	Foetal (Uterine) Dose	3 months
Secondary	Signal to Noise Ratio	Image Quality - Objective Variable	3 months
Secondary	Contrast to Noise Ratio	Image Quality - Objective Variable	3 months
Secondary	Mean Pulmonary Trunk Enhancement	Image Quality - Objective Variable (Hounsfield Units)	3 months
Secondary	Subjective Imaging Quality Grade	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.	3 months