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Prediction Value of Ecg on Coronary Slow-flow (PECS)

6 de enero de 2016 actualizado por: Xiao-dong Zhuang, Sun Yat-sen University

Prediction Value of Ecg on Coronary Slow-flow (PECS) Study

The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Coronary slow flow (CSF) phenomenon, which is characterized by delayed coronary opacification in the absence of obstructive epicardial coronary artery disease, is a relatively common finding in patients undergoing routine coronary angiography and is often associated with chest pain. In some patients with CSF, blood flow may be heterogeneously distributed in the three coronary arteries, suggesting the heterogeneously distributed microvascular dysfunction in the myocardium. However, the vessel heterogeneity of Thrombolysis in Myocardial Infarction (TIMI) frame count (TFC) has not been fully elucidated.

P-wave dispersion (PWD) is defined as the difference between the longest and the shortest P-wave duration recorded from multiple different surface electrocardiogram (ECG) leads, and it has been reported to be associated with inhomogeneous and discontinuous propagation of sinus impulses5, which are well known electrophysiologic characteristics of the atrium prone to fibrillation. Although it is plausible to hypothesize that PWD might be associated with the heterogeneously distributed microvascular dysfunction, and previous studies have demonstrated the abnormal PWD in patients with CSF, the correlation between TFC heterogeneity and PWD has never been evaluated.

In this study, the investigators aimed to investigate the vessel heterogeneity of TFC in the three coronary arteries, and its relation to PWD, in patients with CSF and otherwise normal coronary arteries.

Tipo de estudio

De observación

Inscripción (Actual)

998

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

    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510080
        • Xiaodong Zhaung

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography. Diagnosis of CSF was based on thrombolysis in myocardial infarction (TIMI) frame count (TFC).

Descripción

Inclusion Criteria:

  • All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography

Exclusion Criteria:

  • Valvular or congenital heart disease
  • Atrial fibrillation or other arrhythmia that would interfere with ECG analysis
  • Left ventricular hypertrophy
  • Myocardial or pericardial disease
  • Chronic obstructive pulmonary disease, or electrolyte abnormalities.
  • Subjects taking antiarrhythmic, antiischemic, β-blocker, or calcium-channel blocker medications were also excluded from the study.

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
CSF group
consecutive patients with angiographically documented CSF
angiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, of blood vessels and organs of the body, with particular interest in the arteries, veins, and the heart chambers. This is traditionally done by injecting a radio-opaque contrast agent into the blood vessel and imaging using X-ray based techniques such as fluoroscopy.
control group
age- and gender-matched control subjects
angiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, of blood vessels and organs of the body, with particular interest in the arteries, veins, and the heart chambers. This is traditionally done by injecting a radio-opaque contrast agent into the blood vessel and imaging using X-ray based techniques such as fluoroscopy.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Average thrombolysis in myocardial infarction (TIMI) frame count (TFC) in the three coronary arteries and its relation to P waves parameters on ECG in patients with CSF and otherwise normal coronary arteries
Periodo de tiempo: 24-72 hours
The first frame was defined as the frame in which concentrated dye occupies the full width of the proximal coronary artery lumen, touching both borders of the lumen, and indicates forward motion down the artery. The final frame counted is that in which the contrast first reaches the distal predefined landmark branch without the necessity for full opacification. The difference between maximum and minimum P wave duration (Pmax and Pmin) was calculated from the 12-lead ECG and defined as PWD.
24-72 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
maximum and minimum P wave duration (Pmax and Pmin) and major adverse cardiac events (MACE) in patients with CSF and otherwise normal coronary arteries
Periodo de tiempo: 24 hours-30 days
The occurrence of major adverse cardiac events, defined as (1) death, (2) nonfatal myocardial infarction, or (3) target vessel revascularization. Myocardial infarction was diagnosed by a rise in the creatine kinase level to more than twice the upper normal limit with an increased creatine kinase-MB. Target lesion revascularization was defined as a repeat intervention (surgical or percutaneous) to treat a luminal stenosis within the stent or in the 5-mm distal or proximal segments adjacent to the stent. Target vessel revascularization was defined as a reintervention driven by any lesion located in the same epicardial vessel. Thrombotic stent occlusion was angiographically documented as a complete occlusion (TIMI flow 0 or 1) or a flow-limiting thrombus (TIMI flow 1 or 2) of a previously successfully treated artery.
24 hours-30 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: zhimin du, MD, fitst affiliated hospital of SYSU

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

1 de enero de 2014

Finalización primaria (Actual)

1 de octubre de 2015

Finalización del estudio (Actual)

1 de octubre de 2015

Fechas de registro del estudio

Enviado por primera vez

3 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

6 de enero de 2016

Publicado por primera vez (Estimar)

8 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de enero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

6 de enero de 2016

Última verificación

1 de enero de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PECS-sysu

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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