Comparison of 3 Diagnostic Strategies of PE: Planar V/Q Scan, CTPA, and V/Q SPECT.

Study Overview
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Brief Summary
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Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes patient to the risk of potentially fatal recurrence. False positive testing exposes patients to potentially fatal unduly side effects of anticoagulants. Current diagnostic strategies rely on the sequential use of pretest clinical probability, Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan. Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA are its higher radiation dose and contraindications (renal failure). In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30% increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis of over-diagnosing and over-treating PE when using CTPA. V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has been reported to improve the diagnostic performances of the test, which could reduce the number of non-conclusive tests and allow simplified diagnostic algorithms. The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to the two usual approaches responding rightly to the two mains issues and combining the advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower radiation exposure, no contraindication). Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.

Official Title
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Comparison of 3 Diagnostic Strategies of Pulmonary Embolism : Planar Ventilation-perfusion Scintigraphy (Planar V/Q Scan), Computed Tomography Pulmonary Angiography (CTPA), and V/Q Single Photon Emission Computed Tomography (SPECT)

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: Planar V/Q-based strategy
* Device: CTPA-based strategy
* Device: V/Q SPECT-based strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with a clinically suspected PE (defined as an acute onset of new or worsening shortness of breath, chest pain, hemoptysis, presyncope, or syncope) without another obvious apparent cause. High pretest clinical probability of PE or a non-high pretest clinical probability but a positive D-Dimer test. Exclusion Criteria: Age less than 18 years Patients with already confirmed PE Patients with a clinically suspected high-risk pulmonary embolism (hypotension or shock) Use of therapeutic doses of anticoagulants for more than 48 hours Other indication for long-term use of anticoagulants Contraindication to contrast media (including renal insufficiency with a creatinine clearance lower than 30 ml/min) Life expectancy less than 3 months Unable/unwilling to give informed consent Unlikely to comply with study follow-up Ongoing pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Planar V/Q-based strategy<br>Control arm | Device: Planar V/Q-based strategy<br>* Strategy based on planar pulmonary scintigraphy<br>|
| Active Comparator: CTPA-based strategy<br>Control arm | Device: CTPA-based strategy<br>* Strategy based on pulmonary angiography<br>|
| Experimental: V/Q SPECT-based strategy<br>Experimental arm | Device: V/Q SPECT-based strategy<br>* Strategy based on pulmonary tomoscintigraphy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic events rate in a 3 month follow-up period in patients left untreated after a negative diagnostic strategy. | Rate of symptomatic objectively confirmed thromboembolic events during the 3-month follow-up period in patients left untreated after a negative diagnostic work-up in V/Q SPECT-based strategy in comparison with planar V/Q-based strategy and CTPA-based strategy. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of PE diagnostic in each arm | Proportion of patients deemed to have PE according to the strategy in each arm. | 3 months | 
| Proportion of additionnal tests required in each arm | Proportion of patients for whom additional tests are requested in each arm. | 3 months | 
| Major bleeding incidence in each arm | Incidence of major bleeding episodes in each arm. | 3 months | 
| Incidence and cause of death in each arm | Incidence and cause of death in each arm | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary embolism