Exercise Echocardiography on LV Mechanics in Patients With CAD: a Speckle-tracking Echocardiography
26 de marzo de 2021 actualizado 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
De observación
Inscripción (Anticipado)
90
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Taichung
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Wufeng, Taichung, Taiwán, 413
- Reclutamiento
- Asia University Hospital
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Investigador principal:
- Yu-Chieh Huang, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
acute myocardial infarction diagnosed by a physician and undergoing percutaneous coronary intervention
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The alterations of LV mechanics responses to a 3-min low dose exercise stress echocardiography following time.
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiopulmonary fitness
Periodo de tiempo: detected at the day 30, 60, and 180 after discharge.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: LI-Wei Chou, PhD, China Medical University Hospital/Asia University Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de enero de 2021
Finalización primaria (Anticipado)
31 de julio de 2022
Finalización del estudio (Anticipado)
31 de julio de 2022
Fechas de registro del estudio
Enviado por primera vez
26 de febrero de 2021
Primero enviado que cumplió con los criterios de control de calidad
26 de marzo de 2021
Publicado por primera vez (Actual)
1 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
26 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CMUH108-REC2-180
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .