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1.
J Am Coll Cardiol ; 82(16): 1598-1610, 2023 10 17.
Artigo em Inglês | MEDLINE | ID: mdl-37821170

RESUMO

BACKGROUND: Flurpiridaz F-18 (flurpiridaz) is a novel positron emission tomography (PET) myocardial perfusion imaging tracer. OBJECTIVES: The purpose of this study was to further assess the diagnostic efficacy and safety of flurpiridaz for the detection and evaluation of coronary artery disease (CAD) defined as ≥50% stenosis by quantitative invasive coronary angiography (ICA). METHODS: In this second phase 3 prospective multicenter clinical study, 730 patients with suspected CAD from 48 clinical sites in the United States, Canada, and Europe were enrolled. Patients underwent 1-day rest/stress flurpiridaz PET and 1- or 2-day rest-stress Tc-99m-labeled single photon emission computed tomography (SPECT) before ICA. PET and SPECT images were read by 3 experts blinded to clinical and ICA data. RESULTS: A total of 578 patients (age 63.7 ± 9.5 years) were evaluable; 32.5% were women, 52.3% had body mass index ≥30 kg/m2, and 33.6% had diabetes. Flurpiridaz PET met the efficacy endpoints of the study; its sensitivity and specificity were significantly higher than the prespecified threshold value by 2 of the 3 readers. The sensitivity of flurpiridaz PET was higher than SPECT (80.3% vs 68.7%; P = 0.0003) and its specificity was noninferior to SPECT (63.8% vs 61.7%; P = 0.0004). PET area under the receiver-operating characteristic curves were higher than SPECT in the overall population (0.80 vs 0.68; P < 0.001), women, and obese patients (P < 0.001 for both). Flurpiridaz PET was superior to SPECT (P < 0.001) for perfusion defect size/severity evaluation, image quality, diagnostic certainty, and radiation exposure. Flurpiridaz PET was safe and well tolerated. CONCLUSIONS: This second flurpiridaz PET myocardial perfusion imaging trial shows that flurpiridaz has utility as a new tracer for CAD detection, specifically in women and obese patients. (An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz [18F] Injection PET MPI in the Detection of Coronary Artery Disease [CAD]; NCT03354273).


Assuntos
Doença da Artéria Coronariana , Imagem de Perfusão do Miocárdio , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Artérias , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Imagem de Perfusão do Miocárdio/métodos , Obesidade , Tomografia por Emissão de Pósitrons/métodos , Estudos Prospectivos , Compostos Radiofarmacêuticos/farmacologia , Tomografia Computadorizada de Emissão de Fóton Único/métodos
2.
Ann Nucl Med ; 36(6): 507-514, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35192160

RESUMO

PURPOSE: To estimate the interobserver agreement of the Carimas software package (SP) on global, regional, and segmental levels for the most widely used myocardial perfusion PET tracer-Rb-82. MATERIALS AND METHODS: Rest and stress Rb-82 PET scans of 48 patients with suspected or known coronary artery disease (CAD) were analyzed in four centers using the Carimas SP. We considered values to agree if they simultaneously had an intraclass correlation coefficient (ICC) > 0.75 and a difference < 20% of the median across all observers. RESULTS: The median values on the segmental level were 1.08 mL/min/g for rest myocardial blood flow (MBF), 2.24 mL/min/g for stress MBF, and 2.17 for myocardial flow reserve (MFR). For the rest MBF and MFR, all the values at all the levels fulfilled were in excellent agreement. For stress MBF, at the global and regional levels, all the 24 comparisons showed excellent agreement. Only 1 out of 102 segmental comparisons (seg. 14) was over the adequate agreement limit-23.5% of the median value (ICC = 0.95). CONCLUSION: Interobserver agreement for Rb-82 PET myocardial perfusion quantification analyzed with Carimas is good at any LV segmentation level-global, regional, and segmental. It is good for all the estimates-rest MBF, stress MBF, and MFR.


Assuntos
Doença da Artéria Coronariana , Imagem de Perfusão do Miocárdio , Doença da Artéria Coronariana/diagnóstico por imagem , Circulação Coronária/fisiologia , Humanos , Variações Dependentes do Observador , Perfusão , Tomografia por Emissão de Pósitrons , Reprodutibilidade dos Testes , Radioisótopos de Rubídio , Software
4.
J Nucl Cardiol ; 29(5): 2543-2550, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34409572

RESUMO

PURPOSE: To cross-compare three software packages (SPs)-Carimas, FlowQuant, and PMOD-to quantify myocardial perfusion at global, regional, and segmental levels. MATERIALS AND METHODS: Stress N-13 ammonia PET scans of 48 patients with HCM were analyzed in three centers using Carimas, FlowQuant, and PMOD. Values agreed if they had an ICC > 0.75 and a difference < 20% of the median across all observers. RESULTS: When using 1TCM on the global level, the agreement was good, and the maximum difference between 1TCM MBF values was 17.2% (ICC = 0.83). On the regional level, the agreement was acceptable except in the LCx region (25.5% difference, ICC = 0.74) between FlowQuant and PMOD. Carimas-1TCM agreed well with PMOD-1TCM and FlowQuant-1TCM. Values obtained with FlowQuant-1TCM had a somewhat lesser agreement with PMOD-1TCM, especially at the segmental level. CONCLUSIONS: The global and regional MBF values (with one exception) agree well between the different software packages. There is significant variability in segmental values, mainly located in the LCx region and segments. Out of the studied tools, Carimas can be used interchangeably with both PMOD and FlowQuant for 1TCM implementation on all levels-global, regional, and segmental.


Assuntos
Imagem de Perfusão do Miocárdio , Amônia , Circulação Coronária , Humanos , Perfusão , Tomografia por Emissão de Pósitrons , Reprodutibilidade dos Testes , Software
5.
JACC Cardiovasc Imaging ; 7(11): 1119-1127, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25306543

RESUMO

OBJECTIVES: The purpose of this study was to compare myocardial blood flow (MBF) and myocardial flow reserve (MFR) estimates from rubidium-82 positron emission tomography ((82)Rb PET) data using 10 software packages (SPs) based on 8 tracer kinetic models. BACKGROUND: It is unknown how MBF and MFR values from existing SPs agree for (82)Rb PET. METHODS: Rest and stress (82)Rb PET scans of 48 patients with suspected or known coronary artery disease were analyzed in 10 centers. Each center used 1 of 10 SPs to analyze global and regional MBF using the different kinetic models implemented. Values were considered to agree if they simultaneously had an intraclass correlation coefficient >0.75 and a difference <20% of the median across all programs. RESULTS: The most common model evaluated was the Ottawa Heart Institute 1-tissue compartment model (OHI-1-TCM). MBF values from 7 of 8 SPs implementing this model agreed best. Values from 2 other models (alternative 1-TCM and Axially distributed) also agreed well, with occasional differences. The MBF results from other models (e.g., 2-TCM and retention) were less in agreement with values from OHI-1-TCM. CONCLUSIONS: SPs using the most common kinetic model-OHI-1-TCM-provided consistent results in measuring global and regional MBF values, suggesting that they may be used interchangeably to process data acquired with a common imaging protocol.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Imagem de Perfusão do Miocárdio/métodos , Compostos Radiofarmacêuticos , Radioisótopos de Rubídio , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/fisiopatologia , Europa (Continente) , Feminino , Hemodinâmica , Humanos , Interpretação de Imagem Assistida por Computador , Japão , Masculino , Pessoa de Meia-Idade , Modelos Cardiovasculares , Variações Dependentes do Observador , Ontário , Tomografia por Emissão de Pósitrons , Valor Preditivo dos Testes , Compostos Radiofarmacêuticos/farmacocinética , Reprodutibilidade dos Testes , Radioisótopos de Rubídio/farmacocinética , Software , Estados Unidos
6.
Eur J Nucl Med Mol Imaging ; 33(8): 955-9, 2006 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16819582

RESUMO

Advances in medical imaging now make it possible to investigate any patient with cardiovascular disease using multiple methods which vary widely in their technical requirements, benefits, limitations and costs. The appropriate use of alternative tests requires their integration into joint clinical diagnostic services where experts in all methods collaborate. This statement summarises the principles that should guide developments in cardiovascular diagnostic services.


Assuntos
Doenças Cardiovasculares/diagnóstico , Diagnóstico por Imagem/tendências , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/tendências , Técnicas de Diagnóstico Cardiovascular/tendências , Europa (Continente) , Humanos
7.
Eur Heart J ; 27(14): 1750-3, 2006 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16820369

RESUMO

Advances in medical imaging now make it possible to investigate any patient with cardiovascular disease using multiple methods which vary widely in their technical requirements, benefits, limitations, and costs. The appropriate use of alternative tests requires their integration into joint clinical diagnostic services where experts in all methods collaborate. This statement summarizes the principles that should guide developments in cardiovascular diagnostic services.


Assuntos
Doenças Cardiovasculares/diagnóstico , Diagnóstico por Imagem/tendências , Cardiologia/educação , Consenso , Educação Médica Continuada , Europa (Continente) , Medicina Baseada em Evidências , Humanos , Pesquisa
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