MIRACLE: MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: MRPA
patients will receive an extra MRPA, on top of the standard CTPA
Diagnostic Test: CPTA
patients will receive an extra MRPA, on top of the standard CTPA
|
Outcome Measures
Primary Outcome Measures
- Sensitivity [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 [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
Secondary Outcome Measures
- To determine the negative predictive value of MRPA [At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months]
compared to CTPA
- To determine the positive predictive value of MRPA [At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months]
compared to CTPA
- To determine the accuracy of MRPA [At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months]
compared to CTPA
- To determine the inter-observer agreement / variability of MRPA [At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months]
compared to CTPA
- To determine the feasibility in daily clinical practice of MRPA [At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mentally competent
-
18 years old
Exclusion Criteria:
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Regular exclusion criteria for MR examination,
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Contrast allergy,
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Hemodynamic instability,
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Severe respiratory insufficiency
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Immobile patient.
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Pregnancy
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Dialysis patients
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COVID-19 positive patients
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Noordwest Ziekenhuisgroep
- Leiden University Medical Center
Investigators
- Study Chair: Remy Geenen, Noordwest Ziekenhuisgroep
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL90098.029.22