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Atrial Fibrillation in Relationship to Plasma Biomarkers (AFISBIO II)

13. januar 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Diagnostisk test: 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).
Diagnostisk test: 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
Diagnostisk test: ECG Holter monitor
Patient receives an ECG Holter for a 7-day monitoring.
Diagnostisk test: Standardized Mini-Mental Status Exam (SMMSE)
A screening test for evaluating cognitive performance of patients done in the clinician's office.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of AF
Tidsramme: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.
Incidence of AF
Tidsramme: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Within 14 days from Inclusion.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cardiovascular (CV) death
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Premedix Academy

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. desember 2020

Primær fullføring (Forventet)

1. desember 2024

Studiet fullført (Forventet)

1. desember 2024

Datoer for studieregistrering

Først innsendt

10. januar 2021

Først innsendt som oppfylte QC-kriteriene

13. januar 2021

Først lagt ut (Faktiske)

15. januar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0012020

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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