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Atrial Fibrillation in Relationship to Plasma Biomarkers (AFISBIO II)

13. januar 2021 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Premedix Academy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. december 2020

Primær færdiggørelse (Forventet)

1. december 2024

Studieafslutning (Forventet)

1. december 2024

Datoer for studieregistrering

Først indsendt

10. januar 2021

Først indsendt, der opfyldte QC-kriterier

13. januar 2021

Først opslået (Faktiske)

15. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0012020

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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