Atrial Fibrillation in Relationship to Plasma Biomarkers
AFISBIO II
1 other identifier
observational
300
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2020
CompletedFirst Submitted
Initial submission to the registry
January 10, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 15, 2021
January 1, 2021
4 years
January 10, 2021
January 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevalence of AF
AF duration \> 30s on surface ECG
Within 14 days from Inclusion.
Incidence of AF
AF duration \> 30s on surface ECG
Within 14 days from Inclusion.
Secondary Outcomes (8)
Cardiovascular (CV) death
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
All cause death
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
CV death + nonfatal stroke + nonfatal myocardial infarction
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Ischemic stroke
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Cognitive decline assessed by Mini-Mental State Examination
Day 350-380 from inclusion (Follow-up 4) - Day 1080-1110 from inclusion (Follow-up 6)
- +3 more secondary outcomes
Study Arms (1)
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.
Interventions
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
A screening test for evaluating cognitive performance of patients done in the clinician's office.
Eligibility Criteria
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.
You may qualify if:
- AGE \> 50 years
- No history of supraventricular arrhythmia
- CHADSVASc score \> 2 in men (\> 3 in female)
- Written informed consent is obtained before any study-related assessment is performed
- 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
- +1 more criteria
You may not qualify if:
- History of any supraventricular or ventricular arrhythmia (excluding premature contractions and 1st degree AV block)
- History of cardiac surgery
- Diabetes mellitus type 2
- Reduced LVEF (\<50%)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Premedix Academylead
Study Sites (6)
University Hospital Bratislava - Old Town Hospital
Bratislava, 813 69, Slovakia
University Hospital Bratislava - Hospital Ruzinov
Bratislava, 826 06, Slovakia
University Hospital Bratislava - Hospital of the Academician Ladislav Dérer
Bratislava, 833 05, Slovakia
National Institute for Cardiovascular Diseases
Bratislava, 833 48, Slovakia
Hospital Malacky
Malacky, Slovakia
Faculty Hospital Nitra
Nitra, 950 01, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2021
First Posted
January 15, 2021
Study Start
December 4, 2020
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 15, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share