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Comparison of three diagnostic strategies for suspicion of pulmonary embolism: planar ventilation-perfusion scan (V/Q), CT pulmonary angiography (CTPA) and single photon emission CT ventilation-perfusion scan (SPECT V/Q): a protocol of a randomised controlled trial.
Le Pennec, Romain; Le Roux, Pierre-Yves; Robin, Philippe; Couturaud, Francis; Righini, Marc; Le Gal, Grégoire; Salaun, Pierre-Yves.
Afiliação
  • Le Pennec R; CHU Cavale Blanche, Brest, France romain.lepennec@gmail.com.
  • Le Roux PY; CHU Cavale Blanche, Brest, France.
  • Robin P; CHU Cavale Blanche, Brest, France.
  • Couturaud F; CHU Cavale Blanche, Brest, France.
  • Righini M; University of Geneva, Switzerland, Geneva, Switzerland.
  • Le Gal G; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
  • Salaun PY; CHU Cavale Blanche, Brest, France.
BMJ Open ; 14(5): e075712, 2024 May 15.
Article em En | MEDLINE | ID: mdl-38754880
ABSTRACT

INTRODUCTION:

Pulmonary embolism (PE) is a challenge to diagnose and when missed, exposes patients to potentially fatal recurrent events. Beyond CT pulmonary angiography (CTPA) and planar ventilation/perfusion (V/Q) scan, single photon emission CT (SPECT) V/Q emerged a new diagnostic modality of scintigraphic acquisition that has been reported to improve diagnostic performances. To date, no management outcome study or randomised trial evaluated an algorithm based on SPECT V/Q for PE diagnosis. We present the design of a randomised multicentre, international management study comparing SPECT V/Q with validated strategies. MATERIAL AND

METHODS:

We will include a total of 3672 patients with suspected PE requiring chest imaging, randomised into three different groups, each using a different diagnostic strategy based on SPECT V/Q, CTPA and planar V/Q scan. Randomisation will be unbalanced (211), with twice as many patients in SPECT V/Q arm (n=1836) as in CTPA and planar V/Q arms (n=918 in each). Our primary objective will be to determine whether a diagnostic strategy based on SPECT V/Q is non-inferior to previously validated strategies in terms of diagnostic exclusion safety as assessed by the 3-month risk of thromboembolism in patients with a negative diagnostic workup. Secondary outcomes will be the proportion of patients diagnosed with PE in each arm, patients requiring additional tests, the incidence of major and clinically relevant non-major bleeding and the incidence and cause of death in each arm. ETHICS AND DISSEMINATION This trial is funded by a grant from Brest University Hospital and by INVENT. The study protocol was approved by Biomedical Research Ethics Committee. The investigator or delegate will obtain signed informed consent from all patients prior to inclusion in the trial. Our results will inform future clinical practice guidelines and solve the current discrepancy between nuclear medicine guidelines and clinical scientific society guidelines. TRIAL REGISTRATION NUMBER NCT02983760.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Embolia Pulmonar / Tomografia Computadorizada de Emissão de Fóton Único / Angiografia por Tomografia Computadorizada / Perfusão Limite: Female / Humans / Male Idioma: En Revista: BMJ Open Ano de publicação: 2024 Tipo de documento: Article País de afiliação: França País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Embolia Pulmonar / Tomografia Computadorizada de Emissão de Fóton Único / Angiografia por Tomografia Computadorizada / Perfusão Limite: Female / Humans / Male Idioma: En Revista: BMJ Open Ano de publicação: 2024 Tipo de documento: Article País de afiliação: França País de publicação: Reino Unido