The OPTICA Study - The Optimised Computed Tomography Pulm... | NCT04179487

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

NCT04179487

Sponsor

University College Dublin

Status

Unknown status

Last Update Posted

Dec 2, 2019Actual

Enrollment

464Estimated

Phase

Not provided

Conditions

Pulmonary Embolism
Pregnancy Related
Venous Thromboembolism

Interventions

OPTICA CTPA Protocol

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2018Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Nov 25, 2019

First Submission Date that Met QC Criteria

Nov 25, 2019

First Posted Date

Nov 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2019

Last Update Posted Date

Dec 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter MacMahon, Professor Peter J Mac Mahon, MB BCH BAO, BMedSci, MRCPI, FFRRCSI., Mater Misericordiae University HospitalPrincipal Investigator

Lead Sponsor

University College DublinOTHER

Collaborators

Name	Class
Mater Misericordiae University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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".

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

464Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant Patients with Suspected PE		Pregnant Patients with Suspected pulmonary embolism undergoing low dose CT pulmonary angiogram	Diagnostic Test: OPTICA CTPA Protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPTICA CTPA Protocol	Diagnostic Test	Low dose CT pulmonary angiogram protocol	Pregnant Patients with Suspected PE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Maternal Effective Dose	Maternal Effective Dose	3 months
Breast Radiation Dose	Breast Dose	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant patients with a suspected pulmonary embolism
Age≥18 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant Patients with Suspected pulmonary embolism

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ciara Gillespie, MB BCH BAO	Contact	+353 1 8032000	4230	ciaragillespie@mater.ie
Peter MacMahon, MB BCH BAO	Contact	+353 1 8032000		pmacmahon@mater.ie

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mater Misericordiae University Hospital	Recruiting	Dublin		D07R2WY	Ireland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30921536	Background	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.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis