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Atrial Fibrillation in Relationship to Plasma Biomarkers (AFISBIO II)

13 de enero de 2021 actualizado por: Premedix Academy

The general objective of this study is to:

A. To identify novel plasmatic biomarkers associated with prevalent/incident atrial fibrillation in patients with high risk for AF and stroke.

B. To assess predictive ability of novel plasmatic biomarkers (especially apelin and miRNAs) on prevalent/incident atrial fibrillation in patients with high risk for AF and stroke.

C. To validate predictive models from previous studies based on comorbidities, age, sex, BMI, NT-proBNP, FGF-23, IGF-1 and IGFBP-1 on prevalent/incident AF in patients with high risk for AF and stroke.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Atrial fibrillation (AF) is the most common sustained arrhythmia, associated with an increased risk of stroke, heart failure, and mortality. Despite the high prevalence, AF may be asymptomatic and consequently unrecognized. Detection of asymptomatic AF is challenging as only a minority of the patients is diagnosed during standard examinations with a 12 - lead ECG or a 24h ECG Holter monitoring. Furthermore, prolonged ECG monitoring is costly and can be inconvenient for the patients. Documented AF causes 15% of ischemic strokes. However, approximately 25% of ischemic strokes is of an unknown etiology. It is believed that undetected asymptomatic AF is responsible for some of these strokes.

Plasmatic biomarkers might be of importance in the early diagnosis of AF. Several plasmatic biomarkers have been studied in order to find an association with AF. Cardiac biomarkers such as natriuretic peptides and high-sensitivity troponins are increased in patients with AF. A novel biomarker that is depending on left atrial stretching and ionotropic effects is apelin. In our previous research we discovered that apelin is associated with AF, negatively correlates with AF burden, but only in patients without reduced LVEF. Similarly, parameters reflecting thrombogenesis, such as Fibrinogen and fibrin D-dimer were also found to be associated with the arrhythmia. Other protein biomarkers have been studied in relation to AF incidence. Insulin-like growth factor-binding protein 1 (IGFBP-1) and Insulin-like growth factor 1 (IGF-1) have shown an association with higher risk of incident AF. Previous research also indicated Fibroblast growth factor 23 (FGF-23) to be associated with AF.

However, biomarkers, such as the inflammatory markers high-sensitivity CRP have shown conflicting results.

Finally, in the last years, circulating microRNAs emerged as a promising biomarker of AF, having important function in suppression of messenger RNA responsible for electric and structural remodeling of the left atria.

In our previous case-matched study we discovered that selected miRNAs were associated with paroxysmal AF.

Tipo de estudio

De observación

Inscripción (Anticipado)

300

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.

Estudio Contacto

  • Nombre: Allan Böhm, MD, PhD, MBA, FESC
  • Número de teléfono: +421 907 411 499
  • Correo electrónico: allan.bohm@gmail.com

Ubicaciones de estudio

  • Eslovaquia
      • Bratislava, Eslovaquia, 813 69
        • Reclutamiento
        • University Hospital Bratislava - Old Town Hospital
        • Contacto:
          • Martin Čaprnda, MD, PhD
        • Investigador principal:
          • Martin Čaprnda, MD, PhD
      • Bratislava, Eslovaquia, 826 06
        • Reclutamiento
        • University Hospital Bratislava - Hospital Ruzinov
        • Contacto:
          • Ján Páleš, MD
        • Investigador principal:
          • Ján Páleš, MD
      • Bratislava, Eslovaquia, 833 05
        • Reclutamiento
        • University Hospital Bratislava - Hospital of the Academician Ladislav Dérer
        • Contacto:
          • Tereza Hlavatá, MD
        • Investigador principal:
          • Tereza Hlavatá, MD
      • Bratislava, Eslovaquia, 833 48
        • Reclutamiento
        • National Institute for Cardiovascular Diseases
        • Contacto:
          • Allan Böhm, PhD, MBA, FESC
          • Número de teléfono: +421 907 411 499
          • Correo electrónico: allan.bohm@gmail.com
        • Investigador principal:
          • Allan Böhm, PhD, MBA, FESC
      • Malacky, Eslovaquia
        • Reclutamiento
        • Hospital Malacky
        • Contacto:
          • Tomáš Uher, MD
        • Investigador principal:
          • Tomáš Uher, MD
      • Nitra, Eslovaquia, 950 01
        • Reclutamiento
        • Faculty Hospital Nitra
        • Contacto:
          • Peter Snopek, MD
        • Investigador principal:
          • Peter Snopek, MD
        • Sub-Investigador:
          • Radovan Hurčík, MD

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

50 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Patients from Slovak hospitals and outpatient clinics in sinus rhythm without history of AF, with high risk for ischemic stroke and AF. CHA2DS2-VASc score > 2 (for females > 3) and with more than 3 specific criteria for inclusion.

Descripción

Inclusion Criteria:

General inclusion criteria:

  • AGE > 50 years
  • No history of supraventricular arrhythmia
  • Sinus rhythm at inclusion
  • CHADSVASc score > 2 in men (> 3 in female)
  • More than 3 specific criteria for inclusion
  • Written informed consent is obtained before any study-related assessment is performed

Specific inclusion criteria:

  • Age > 65
  • Age > 75
  • BMI > 30
  • Heart failure with preserved LVEF (according to ESC GL for HF)
  • Ischemic stroke
  • Left atrial diameter > 45mm
  • Chronic obstructive pulmonary disease
  • Arterial hypertension
  • PR interval > 200ms
  • History of MI or (objective evidence of) chronic coronary syndrome
  • Peripheral artery disease
  • Thyroid disease

Exclusion Criteria:

  • History of any supraventricular or ventricular arrhythmia (excluding premature contractions and 1st degree AV block)
  • Therapy with anticoagulants at the time of inclusion
  • Acute coronary syndrome less than 1 month prior to inclusion
  • History of cardiac surgery
  • Diabetes mellitus type 2
  • Reduced LVEF (<50%)
  • Acute or decompensated heart failure at the time of inclusion
  • Cardiomyopathy
  • Systemic inflammatory disease or acute inflammatory disease
  • Active malignancy
  • Alcoholism (≥ 8 drinks/week)
  • Renal Disease (Dialysis/ transplant/ CrCl < 1ml/s)
  • Liver disease (cirrhosis/ transaminase > 3x ULT/ bilirubin > 2x ULT)
  • Severe or moderate mitral stenosis
  • Pregnancy

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
Study Group
Patients in sinus rhythm without history of AF, with high risk for ischemic stroke and AF. CHA2DS2-VASc score > 2 (for females > 3) and with more than 3 specific criteria for inclusion.
Prueba de diagnóstico: Peripheral blood samples for routine analysis including NT-proBNP and plasmatic biomarkers.
Sampling of peripheral venous blood for analysis of plasma concentration of plasmatic markers (Apelin, microRNA, FGF-23, IGF-1, IGFBP-1) and routine analysis (laboratory parameters: NT-proBNP, D-dimer, Creatinine Clearance, CRP, Hs-troponin).
Prueba de diagnóstico: Echocardiography

ECHO parameters:

  • E/e´
  • Mean e' septal and lateral wall
  • LA volume (Biplane Area-Length Method)
  • Left atrial volume index
  • Diameter of left atrium in PLAX
  • Severe aortic stenosis
  • Severe mitral regurgitation
  • Severe tricuspid regurgitation
  • Left ventricular end-diastolic diameter
  • Interventricular septum
  • Posterior wall
  • LV Mass
  • Left ventricular mass index
Prueba de diagnóstico: ECG Holter monitor
Patient receives an ECG Holter for a 7-day monitoring.
Prueba de diagnóstico: Standardized Mini-Mental Status Exam (SMMSE)
A screening test for evaluating cognitive performance of patients done in the clinician's office.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prevalence of AF
Periodo de tiempo: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.
Incidence of AF
Periodo de tiempo: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardiovascular (CV) death
Periodo de tiempo: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Event occurred or did not occur (Yes/No).
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
All cause death
Periodo de tiempo: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Event occurred or did not occur (Yes/No).
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
CV death + nonfatal stroke + nonfatal myocardial infarction
Periodo de tiempo: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Event occurred or did not occur (Yes/No).
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Ischemic stroke
Periodo de tiempo: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Event occurred or did not occur (Yes/No).
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Cognitive decline assessed by Mini-Mental State Examination
Periodo de tiempo: Day 350-380 from inclusion (Follow-up 4) - Day 1080-1110 from inclusion (Follow-up 6)
Impairment observed and recorded or not observed and not recorded (Yes/No).
Day 350-380 from inclusion (Follow-up 4) - Day 1080-1110 from inclusion (Follow-up 6)
Heart failure
Periodo de tiempo: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)

Event occurred or did not occur (Yes/No). If Yes, HF classification to be indicated based on LVEF:

i. with preserved LVEF (HFpEF) ii. with mid-range LVEF (HFmrEF) iii. with reduced LVEF (HFrEF)
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Hospitalization due to CV cause
Periodo de tiempo: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Event occurred or did not occur (Yes/No).
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Acute coronary syndrome
Periodo de tiempo: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)

Event occurred or did not occur (Yes/No). If Yes, type of ACS to be indicated:

i. Unstable angina ii. NSTEMI iii. STEMI
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)

Colaboradores e Investigadores

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

Patrocinador

Premedix Academy

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)

4 de diciembre de 2020

Finalización primaria (Anticipado)

1 de diciembre de 2024

Finalización del estudio (Anticipado)

1 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

10 de enero de 2021

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2021

Publicado por primera vez (Actual)

15 de enero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de enero de 2021

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

13 de enero de 2021

Última verificación

1 de enero de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0012020

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. .

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