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

November 26, 2019 updated by: Peter MacMahon, University College Dublin

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ireland
      • Dublin, Ireland, D07R2WY
        • Recruiting
        • Mater Misericordiae University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter MacMahon, MB BCH BAO
        • Principal Investigator:
          • Fionnuala NiAinle, MB BCH BAO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant Patients with Suspected pulmonary embolism

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant Patients with Suspected PE
Pregnant Patients with Suspected pulmonary embolism undergoing low dose CT pulmonary angiogram
Diagnostic test: OPTICA CTPA Protocol
Low dose CT pulmonary angiogram protocol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Collaborators

Mater Misericordiae University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2018

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

April 1, 2024

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (ACTUAL)

November 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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