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Atrial Fibrillation in Relationship to Plasma Biomarkers (AFISBIO II)

13 gennaio 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Anticipato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Allan Böhm, MD, PhD, MBA, FESC
  • Numero di telefono: +421 907 411 499
  • Email: allan.bohm@gmail.com

Luoghi di studio

  • Slovacchia
      • Bratislava, Slovacchia, 813 69
        • Reclutamento
        • University Hospital Bratislava - Old Town Hospital
        • Contatto:
          • Martin Čaprnda, MD, PhD
        • Investigatore principale:
          • Martin Čaprnda, MD, PhD
      • Bratislava, Slovacchia, 826 06
        • Reclutamento
        • University Hospital Bratislava - Hospital Ruzinov
        • Contatto:
          • Ján Páleš, MD
        • Investigatore principale:
          • Ján Páleš, MD
      • Bratislava, Slovacchia, 833 05
        • Reclutamento
        • University Hospital Bratislava - Hospital of the Academician Ladislav Dérer
        • Contatto:
          • Tereza Hlavatá, MD
        • Investigatore principale:
          • Tereza Hlavatá, MD
      • Bratislava, Slovacchia, 833 48
        • Reclutamento
        • National Institute for Cardiovascular Diseases
        • Contatto:
        • Investigatore principale:
          • Allan Böhm, PhD, MBA, FESC
      • Malacky, Slovacchia
        • Reclutamento
        • Hospital Malacky
        • Contatto:
          • Tomáš Uher, MD
        • Investigatore principale:
          • Tomáš Uher, MD
      • Nitra, Slovacchia, 950 01
        • Reclutamento
        • Faculty Hospital Nitra
        • Contatto:
          • Peter Snopek, MD
        • Investigatore principale:
          • Peter Snopek, MD
        • Sub-investigatore:
          • Radovan Hurčík, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Test diagnostico: 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).
Test diagnostico: 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
Test diagnostico: ECG Holter monitor
Patient receives an ECG Holter for a 7-day monitoring.
Test diagnostico: Standardized Mini-Mental Status Exam (SMMSE)
A screening test for evaluating cognitive performance of patients done in the clinician's office.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of AF
Lasso di tempo: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.
Incidence of AF
Lasso di tempo: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cardiovascular (CV) death
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Premedix Academy

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 dicembre 2020

Completamento primario (Anticipato)

1 dicembre 2024

Completamento dello studio (Anticipato)

1 dicembre 2024

Date di iscrizione allo studio

Primo inviato

10 gennaio 2021

Primo inviato che soddisfa i criteri di controllo qualità

13 gennaio 2021

Primo Inserito (Effettivo)

15 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 gennaio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 gennaio 2021

Ultimo verificato

1 gennaio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0012020

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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