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Atrial Fibrillation in Relationship to Plasma Biomarkers (AFISBIO II)

13. Januar 2021 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

300

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Allan Böhm, MD, PhD, MBA, FESC
  • Telefonnummer: +421 907 411 499
  • E-Mail: allan.bohm@gmail.com

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
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).

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
Patient receives an ECG Holter for a 7-day monitoring.
A screening test for evaluating cognitive performance of patients done in the clinician's office.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Prevalence of AF
Zeitfenster: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.
Incidence of AF
Zeitfenster: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cardiovascular (CV) death
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Dezember 2020

Primärer Abschluss (Voraussichtlich)

1. Dezember 2024

Studienabschluss (Voraussichtlich)

1. Dezember 2024

Studienanmeldedaten

Zuerst eingereicht

10. Januar 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Januar 2021

Zuerst gepostet (Tatsächlich)

15. Januar 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Januar 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Januar 2021

Zuletzt verifiziert

1. Januar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 0012020

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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