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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04179487
Other study ID # 01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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