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- Ensaio Clínico NCT04824001
Exercise Echocardiography on LV Mechanics in Patients With CAD: a Speckle-tracking Echocardiography
26 de março de 2021 atualizado por: Li-Wei Chou, China Medical University Hospital
Using Exercise Echocardiography to Investigate the Effects of Different Exercise Trainings on Left Ventricular Mechanics in Patients With Coronary Artery Disease: a Speckle-tracking Echocardiography
Recovering blood flow to a coronary stenosis may improve left ventricular (LV) function in patients with coronary artery disease (CAD).
However, the reported data about evaluation of LV function post-percutaneous coronary intervention (PCI) in CAD was limited.
The aim of this study was to compare the LV function measured by 3 min low dose exercise stress echocardiography (ESE) combined 2D speckle tracking echocardiography (STE) in patients with CAD underwent PCI, and to identify factors affecting the change of LV function.
Patients with CAD who underwent acute PCI were enrolled.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
The assessment of temporal changes in systolic and diastolic regional left ventricle function by 2D-STE after successful reperfusion therapy of acute myocardial infarction (AMI).The estimated total number of participants is 90 patients with AMI and treated with successful percutaneous coronary intervention were included in this study.
The echocardiographic measurements were performed in all patients within in-hotpital after PCI procedure, and then followed up at 7, 14, 30, 60 and 180 days after discharge.
Recovery of regional systolic and diastolic myocardial function after acute myocardial infarction evaluated by ESE-STE.
Tipo de estudo
Observacional
Inscrição (Antecipado)
90
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Taichung
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Wufeng, Taichung, Taiwan, 413
- Recrutamento
- Asia University Hospital
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Investigador principal:
- Yu-Chieh Huang, PhD
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
N/D
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
acute myocardial infarction diagnosed by a physician and undergoing percutaneous coronary intervention
Descrição
Inclusion Criteria:
- acute myocardial infarction diagnosed by a physician
- undergoing percutaneous coronary intervention
- Exercise testing and stress echocardiography are performed with the approval of the physician.
Exclusion Criteria:
- Severe cardiac valve disease
- Left bundle branch block
- Uncontrolled diabetes or hypertension
- Orthopedics or other conditions that hinder from exercise
- Uncontrolled sinus tachycardia (greater than 120 beats per minute)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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STEMI
ST-segment elevation myocardial infarction (STEMI) is defined by symptoms of myocardial ischemia accompanied by a persistent elevation of the ST segment on the electrocardiogram (ECG) and the subsequent release of biomarkers of myocardial necrosis.
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Stress echocardiography test.
The standardized exercise test was conducted by 50-W semi-recumbent cycling for 3 min.
Stress echocardiograph images were acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR.
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NSTEMI
If there is elevation of the blood markers suggesting heart damage, but no ST elevation seen on the EKG tracing, this is known as a non ST-elevation myocardial infarction (NSTEMI).
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Stress echocardiography test.
The standardized exercise test was conducted by 50-W semi-recumbent cycling for 3 min.
Stress echocardiograph images were acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The alterations of LV mechanics responses to a 3-min low dose exercise stress echocardiography following time.
Prazo: detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.
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The STE was performed at rest, during exercise and recovery to compare the changes of LV machines following discharge.
The standardized exercise test was conducted by 50-W semirecumbent cycling (Cardiac Stress Table w/Angio) for 3 min.
Stress echocardiograph images were acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR.
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detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cardiopulmonary fitness
Prazo: detected at the day 30, 60, and 180 after discharge.
|
The graded exercise test (GXT) was performed with a cycle ergometer at the day 30 and 180 after discharge.
The GXT comprised of unloaded pedaling for 2 min followed by a continuous increase in work rate (20-30 W) every 3 min until exhaustion (i.e., V˙ O2max).
Minute ventilation (V˙ E), V˙ O2, and CO2 production (V˙ CO2) were measured breath-by-breath using a computer-based system (MasterScreen CPX; Cardinal Health Germany).
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detected at the day 30, 60, and 180 after discharge.
|
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The brain-type natriuretic peptide (BNP) levels
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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BNP levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The high-sensitivity CRP (hsCRP) levels
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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hsCRP levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
|
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The creatine kinase (CK) levels
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The CK levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The creatine kinase-MB (CK-MB) levels
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The CK-MB levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
|
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The troponin I levels
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The troponin I levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The left ventricle wall and cavity dimensions
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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M-mode images were used to determine the LV wall and cavity dimensions at end-systole and end-diastole from a parasternal long axis view.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The left ventricle mass
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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Measurements of LVmass and the short fraction index were automatically derived using standard equations as followed: LVmass(gm) = 0.77 X 10^-3X [(IVS + LVIDd +PW)^3 - (LVIDd)^3 + 2.4]
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The left ventricle ejection fraction
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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LV ejection fraction (LVEF) was determined using the modified Simpson's method from the apical four-chamber views.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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The left ventricle diastolic functions
Prazo: detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
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Analysis of Doppler pulsed wave was performed to determine diastolic transmitral blood flow velocities for peak early (E) and late (A) fillings and was also detected the diastolic mitral annular tissue velocities for peak early (E') and late (A') fillings.
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detected at the detected at the in-hospital and the day 7, 14, 30, 60, and 180 after discharge.ay 30, 60, and 180 after discharge.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: LI-Wei Chou, PhD, China Medical University Hospital/Asia University Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Huang YC, Tsai HH, Fu TC, Hsu CC, Wang JS. High-Intensity Interval Training Improves Left Ventricular Contractile Function. Med Sci Sports Exerc. 2019 Jul;51(7):1420-1428. doi: 10.1249/MSS.0000000000001931.
- Anand IS, Kuskowski MA, Rector TS, Florea VG, Glazer RD, Hester A, Chiang YT, Aknay N, Maggioni AP, Opasich C, Latini R, Cohn JN. Anemia and change in hemoglobin over time related to mortality and morbidity in patients with chronic heart failure: results from Val-HeFT. Circulation. 2005 Aug 23;112(8):1121-7. doi: 10.1161/CIRCULATIONAHA.104.512988. Epub 2005 Aug 15.
- Sikora-Frac M, Zaborska B, Maciejewski P, Budaj A, Bednarz B. Improvement of left ventricular function after percutaneous coronary intervention in patients with stable coronary artery disease and preserved ejection fraction: Impact of diabetes mellitus. Cardiol J. 2021;28(6):923-931. doi: 10.5603/CJ.a2019.0066. Epub 2019 Jul 1.
- Li H, Liu C, Zhang G, Wang C, Sun P, Du G, Tian J. The early alteration of left ventricular strain and dys-synchrony index in breast cancer patients undergoing anthracycline therapy using layer-specific strain analysis. Echocardiography. 2019 Sep;36(9):1675-1681. doi: 10.1111/echo.14460. Epub 2019 Aug 27.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
13 de janeiro de 2021
Conclusão Primária (Antecipado)
31 de julho de 2022
Conclusão do estudo (Antecipado)
31 de julho de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
26 de fevereiro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de março de 2021
Primeira postagem (Real)
1 de abril de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de março de 2021
Última verificação
1 de março de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CMUH108-REC2-180
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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