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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-02

Study Completion Date

2024-03-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Embolism Radiation Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRPA

Intervention Type DIAGNOSTIC_TEST

patients will receive an extra MRPA, on top of the standard CTPA

CPTA

Intervention Type DIAGNOSTIC_TEST

patients will receive an extra MRPA, on top of the standard CTPA

Interventions

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MRPA

patients will receive an extra MRPA, on top of the standard CTPA

Intervention Type DIAGNOSTIC_TEST

CPTA

patients will receive an extra MRPA, on top of the standard CTPA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Mentally competent
* 18 years old

Exclusion Criteria

* Contrast allergy,
* Hemodynamic instability,
* Severe respiratory insufficiency
* Immobile patient.
* Pregnancy
* Dialysis patients
* COVID-19 positive patients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No