Pulmonary EmbolismMIRACLENCT05879380
MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism
An observational study of Pulmonary Embolism and Radiation Exposure, run by Noordwest Ziekenhuisgroep.
Trial summary
Rational: The first choice of imaging modality for patients with a suspicion of pulmonary embolism is CT pulmonary angiography (CTPA). Our goal is to avoid extra cases of cancer due to the carcinogenic effect of ionizing radiation from using CTPA. This carcinogenic effect is greatest in women under 40. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Radiation Exposure
- What is being tested?
- MRPA and CPTA
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2023to 20 Mar 2024
- How long will I take part?
- 1 Day
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population consists of all patients with a suspicion of pulmonary embolisms on all departments of our hospital - including ER, wards, primary lung-heart aid ward - who undergo a CTPA during the study period.
Who may be able to join
- Mentally competent
- 18 years old
Who cannot join
- Regular exclusion criteria for MR examination,
- Contrast allergy,
- Hemodynamic instability,
- Severe respiratory insufficiency
- Immobile patient.
- Pregnancy
- Dialysis patients
- COVID-19 positive patients
Trial locations and contacts
No sites are listed yet.
About this study
Rational: The first choice of imaging modality for patients with a suspicion of pulmonary embolism is CT pulmonary angiography (CTPA). Our goal is to avoid extra cases of cancer due to the carcinogenic effect of ionizing radiation from using CTPA. This carcinogenic effect is greatest in women under 40. In the Netherlands, at least 100,000 CTPA's are performed each year, 10% of which are in women under 40 years old, resulting in at least 10 extra tumors induced per year. The goal is to investigate whether MR Pulmonary angiography (MRPA) can serve as an alternative to CTPA. If it can replace CTPA, this will result in a significant health benefit.
Objective: the primary objective is to determine the sensitivity and specificity of MR Pulmonary Angiography (MRPA) with CT Pulmonary Angiography (CTPA) as the gold standard.
Read more
Secondary outcomes: to determine the clinical applicability of MRPA in daily practice, negative predictive value, positive predictive value, accuracy of MRPA (compared to CTPA), and agreement in assessment between radiologists.
Study design: observational-prospective diagnostic study, an additional MRPA will be performed in patients with a suspicion of pulmonary embolism.
Study population: in patients with clinical suspicion of pulmonary embolism, a standard CTPA is made for exclusion or confirmation of the disease. The study population will consist of 272 patients.
Primary outcome parameters: determining the sensitivity and specificity of MRPA compared to CTPA (gold standard) in patients with a (clinical) suspicion of pulmonary embolism.
Secondary outcome parameters: Determining the negative predictive value, positive predictive value, accuracy, inter-observer agreement with respect to MRPA, and applicability in daily clinical practice.
- Conditions
- Pulmonary Embolism, Radiation Exposure
- Being tested
- MRPA, CPTA
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRPADiagnostic test
patients will receive an extra MRPA, on top of the standard CTPA
CPTADiagnostic test
patients will receive an extra MRPA, on top of the standard CTPA
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of pulmonary embolism | The group suspected of a pulmonary embolism will receive standard care, consisting of the CTPA to see wether they have a pulmonary embolism or not. Additional to this imaging they will receive a MRPA. Receives: Diagnostic Test: MRPA; Diagnostic Test: CPTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
To determine the sensitivity of the MRPA towards CTPA, regarding all patients that have been scanned. Then the sensitivity will be calculated and compared to that of the golden standard CTPA
Measured: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Specificity
To determine the specificity of the MRPA towards CTPA. To determine the specificity of the MRPA towards CTPA, regarding all patients that have been scanned. Then the specificity will be calculated and compared to that of the golden standard CTPA
Measured: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Secondary outcomes (5)
To determine the negative predictive value of MRPA
compared to CTPA
Measured: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the positive predictive value of MRPA
compared to CTPA
Measured: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the accuracy of MRPA
compared to CTPA
Measured: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the inter-observer agreement / variability of MRPA
compared to CTPA
Measured: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the feasibility in daily clinical practice of MRPA
Measured: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start2 Jun 2023 (estimated)
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 272 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Noordwest Ziekenhuisgroep
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Jos Wallis, Noordwest Ziekenhuisgroep
- Investigators
- Remy Geenen, Study chair, Noordwest Ziekenhuisgroep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879380
- Sponsor's protocol ID
- NL90098.029.22
- Acronym
- MIRACLE
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05879380
- Acronym / sponsor ID
- MIRACLE / NL90098.029.22
- Conditions
- Pulmonary Embolism, Radiation Exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Noordwest ZiekenhuisgroepUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 2 Jun 2023 (estimated)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 30 May 2023 (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.
Rational: The first choice of imaging modality for patients with a suspicion of pulmonary embolism is CT pulmonary angiography (CTPA). Our goal is to avoid extra cases of cancer due to the carcinogenic effect of ionizing radiation from using CTPA. This carcinogenic effect is greatest in women under 40. In the Netherlands, at least 100,000 CTPA's are performed each year, 10% of which are in women under 40 years old, resulting in at least 10 extra tumors induced per year. The goal is to investigate whether MR Pulmonary angiography (MRPA) can serve as an alternative to CTPA. If it can replace CTPA, this will result in a significant health benefit.
Objective: the primary objective is to determine the sensitivity and specificity of MR Pulmonary Angiography (MRPA) with CT Pulmonary Angiography (CTPA) as the gold standard.
Secondary outcomes: to determine the clinical applicability of MRPA in daily practice, negative predictive value, positive predictive value, accuracy of MRPA (compared to CTPA), and agreement in assessment between radiologists.
Study design: observational-prospective diagnostic study, an additional MRPA will be performed in patients with a suspicion of pulmonary embolism.
Study population: in patients with clinical suspicion of pulmonary embolism, a standard CTPA is made for exclusion or confirmation of the disease. The study population will consist of 272 patients.
Primary outcome parameters: determining the sensitivity and specificity of MRPA compared to CTPA (gold standard) in patients with a (clinical) suspicion of pulmonary embolism.
Secondary outcome parameters: Determining the negative predictive value, positive predictive value, accuracy, inter-observer agreement with respect to MRPA, and applicability in daily clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of pulmonary embolism | – | Diagnostic Test: MRPA, Diagnostic Test: CPTAThe group suspected of a pulmonary embolism will receive standard care, consisting of the CTPA to see wether they have a pulmonary embolism or not. Additional to this imaging they will receive a MRPA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population consists of all patients with a suspicion of pulmonary embolisms on all departments of our hospital - including ER, wards, primary lung-heart aid ward - who undergo a CTPA during the study period.
Key inclusion criteria (2 listed)
- Mentally competent
- 18 years old
Key exclusion criteria (8 listed)
- Regular exclusion criteria for MR examination,
- Contrast allergy,
- Hemodynamic instability,
- Severe respiratory insufficiency
- Immobile patient.
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 |
|---|---|---|
| MRPApatients will receive an extra MRPA, on top of the standard CTPA | Diagnostic test | Suspicion of pulmonary embolism |
| CPTApatients will receive an extra MRPA, on top of the standard CTPA | Diagnostic test | Suspicion of pulmonary embolism |
Primary outcome
Sensitivity
Time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the sensitivity of the MRPA towards CTPA, regarding all patients that have been scanned. Then the sensitivity will be calculated and compared to that of the golden standard CTPA
Specificity
Time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the specificity of the MRPA towards CTPA. To determine the specificity of the MRPA towards CTPA, regarding all patients that have been scanned. Then the specificity will be calculated and compared to that of the golden standard CTPA
5 secondary outcomes
To determine the negative predictive value of MRPA
Time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the positive predictive value of MRPA
Time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the accuracy of MRPA
Time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the inter-observer agreement / variability of MRPA
Time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the feasibility in daily clinical practice of MRPA
Time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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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.
Remy Geenen study chair
Noordwest Ziekenhuisgroep
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Radiation Exposure, run by Noordwest Ziekenhuisgroep.
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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Jos Wallis (072-54835044, j.w.wallis@nwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.