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

• Conditions: Venous Thromboembolism; Pulmonary Embolism; Pregnancy Related
• Interventions: Diagnostic Test: OPTICA CTPA Protocol

• Registration Number: NCT04179487
• Lead Sponsor: University College Dublin

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 Timeline

• Study Start: 2018-05-29
• Status Verified: 2019-11
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-12-02
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 464

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Patients with Suspected PE	OPTICA CTPA Protocol	Pregnant Patients with Suspected pulmonary embolism undergoing low dose CT pulmonary angiogram

Primary Outcome Measures

Name	Time	Method
Incidence of Venous Thrombo-Embolism (VTE)	3 months	3-month incidence of venous thromboembolism in pregnant patients in whom pulmonary embolism was excluded at baseline CT pulmonary angiogram.

Secondary Outcome Measures

Name	Time	Method
Maternal Effective Dose	3 months	Maternal Effective Dose
Breast Radiation Dose	3 months	Breast Dose
Foetal Radiation Dose	3 months	Foetal (Uterine) Dose
Signal to Noise Ratio	3 months	Image Quality - Objective Variable
Contrast to Noise Ratio	3 months	Image Quality - Objective Variable
Mean Pulmonary Trunk Enhancement	3 months	Image Quality - Objective Variable (Hounsfield Units)
Subjective Imaging Quality Grade	3 months	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.

Trial Locations

Locations (1)

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland