MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— MIRACLE  

Official title:

MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05879380
• Other study ID #: NL90098.029.22
• Status: Not yet recruiting
• Start date: June 2, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: May 2023
• Source: Noordwest Ziekenhuisgroep
• Contact: Jos Wallis
• Phone: 072-54835044
• Email: j.w.wallis[@]nwz.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 272
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mentally competent

• 18 years old

Exclusion Criteria:

• Regular exclusion criteria for MR examination,

• Contrast allergy,

• Hemodynamic instability,

• Severe respiratory insufficiency

• Immobile patient.

• Pregnancy

• Dialysis patients

• COVID-19 positive patients

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Radiation Exposure

Intervention

Diagnostic Test:
• MRPA
patients will receive an extra MRPA, on top of the standard CTPA
• CPTA
patients will receive an extra MRPA, on top of the standard CTPA

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Noordwest Ziekenhuisgroep	Leiden University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Primary	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	At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Secondary	To determine the negative predictive value of MRPA	compared to CTPA	At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Secondary	To determine the positive predictive value of MRPA	compared to CTPA	At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Secondary	To determine the accuracy of MRPA	compared to CTPA	At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Secondary	To determine the inter-observer agreement / variability of MRPA	compared to CTPA	At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
Secondary	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