Pulmonary EmbolismOPTICANCT04179487
The OPTICA Study - The Optimised Computed Tomography Pulmonary Angiography (CTPA) in Pregnancy, Quality and Safety Study
An observational study of Pulmonary Embolism and Pregnancy Related, run by University College Dublin at 1 site in Ireland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pulmonary Embolism, Pregnancy Related, Venous Thromboembolism
- What is being tested?
- OPTICA CTPA Protocol
- How many people
- 464 participants
- Where
- 1 siteIreland
- Study dates
- 29 May 2018to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant Patients with Suspected pulmonary embolism
Who may be able to join
- Pregnant patients with a suspected pulmonary embolism
- Age≥18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin, D07R2WY
Ciara Gillespie, MB BCH BAO, ciaragillespie@mater.ie
Peter MacMahon, MB BCH BAO, pmacmahon@mater.ie
About this study
Official title: 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
Read the 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".
- Being tested
- OPTICA CTPA Protocol
- Keywords
- pulmonary embolism, pregnancy, tomography xray computed, radiation dosage, negative predictive value
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTICA CTPA ProtocolDiagnostic test
Low dose CT pulmonary angiogram protocol
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Patients with Suspected PE | Pregnant Patients with Suspected pulmonary embolism undergoing low dose CT pulmonary angiogram Receives: Diagnostic Test: OPTICA CTPA Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (7)
Maternal Effective Dose
Maternal Effective Dose
Measured: 3 months
Breast Radiation Dose
Breast Dose
Measured: 3 months
Foetal Radiation Dose
Foetal (Uterine) Dose
Measured: 3 months
Signal to Noise Ratio
Image Quality - Objective Variable
Measured: 3 months
Contrast to Noise Ratio
Image Quality - Objective Variable
Measured: 3 months
Mean Pulmonary Trunk Enhancement
Image Quality - Objective Variable (Hounsfield Units)
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start29 May 2018
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Mater Misericordiae University Hospital
- Responsible party
- Principal investigator, Peter MacMahon, Mater Misericordiae University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179487
- Sponsor's protocol ID
- 01
- Acronym
- OPTICA
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30921536
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy
- ClinicalTrials.gov ID
- NCT04179487
- Acronym / sponsor ID
- OPTICA / 01
- Keywords
- pulmonary embolism, pregnancy, tomography xray computed, radiation dosage, negative predictive value
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Mater Misericordiae University Hospital
- Study start
- 29 May 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Patients with Suspected PE | – | Diagnostic Test: OPTICA CTPA ProtocolPregnant Patients with Suspected pulmonary embolism undergoing low dose CT pulmonary angiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant Patients with Suspected pulmonary embolism
Key inclusion criteria (2 listed)
- Pregnant patients with a suspected pulmonary embolism
- Age≥18 years
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTICA CTPA ProtocolLow dose CT pulmonary angiogram protocol | Diagnostic test | Pregnant Patients with Suspected PE |
Primary outcome
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.
7 secondary outcomes
Maternal Effective Dose
Time frame: 3 months
Breast Radiation Dose
Time frame: 3 months
Foetal Radiation Dose
Time frame: 3 months
Signal to Noise Ratio
Time frame: 3 months
Contrast to Noise Ratio
Time frame: 3 months
Mean Pulmonary Trunk Enhancement
Time frame: 3 months
Subjective Imaging Quality Grade
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Background: PubMed 30921536Gillespie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Pregnancy Related, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ciara Gillespie, MB BCH BAO (+353 1 8032000 ext. 4230, ciaragillespie@mater.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Venous Thrombo-Embolism (VTE) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.