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

Noordwest Ziekenhuisgroep

Status: Not yet enrolling

Conditions: Pulmonary Embolism; Radiation Exposure

Treatments: Diagnostic Test: MRPA; Diagnostic Test: CPTA

Study type: Observational

Funder types: Other

Identifiers

NCT05879380

NL90098.029.22

Details and patient eligibility

About

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.

Enrollment: 272 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

272 participants in 1 patient group

Suspicion of pulmonary embolism

Description:

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.

Treatment:

Diagnostic Test: CPTA

Diagnostic Test: MRPA