Atrial FibrillationAFISBIO IINCT04710745
Atrial Fibrillation in Relationship to Plasma Biomarkers
An observational study of Atrial Fibrillation, run by Premedix Academy at 6 sites in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Peripheral blood samples for routine analysis including NT-proBNP and plasmatic biomarkers., Echocardiography and ECG Holter monitor
- How many people
- 300 participants
- Where
- 6 sitesSlovakia
- Study dates
- 4 Dec 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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%)
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Slovakia6 sites, 6 recruiting
- Recruiting
University Hospital Bratislava - Old Town Hospital
Bratislava, 813 69
Martin Čaprnda, MD, PhD
Martin Čaprnda, MD, PhD
- Recruiting
University Hospital Bratislava - Hospital Ruzinov
Bratislava, 826 06
Ján Páleš, MD
Ján Páleš, MD
- Recruiting
University Hospital Bratislava - Hospital of the Academician Ladislav Dérer
Bratislava, 833 05
Tereza Hlavatá, MD
Tereza Hlavatá, MD
- Recruiting
National Institute for Cardiovascular Diseases
Bratislava, 833 48
Allan Böhm, PhD, MBA, FESC, +421 907 411 499, allan.bohm@gmail.com
Allan Böhm, PhD, MBA, FESC
- Recruiting
Hospital Malacky
Malacky
Tomáš Uher, MD
Tomáš Uher, MD
- Recruiting
Faculty Hospital Nitra
Nitra, 950 01
Peter Snopek, MD
Peter Snopek, MD
About this study
The general objective of this study is to:
- To identify novel plasmatic biomarkers associated with prevalent/incident atrial fibrillation in patients with high risk for AF and stroke.
- 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.
- 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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Peripheral blood samples for routine analysis including NT-proBNP and plasmatic biomarkers., Echocardiography, ECG Holter monitor, Standardized Mini-Mental Status Exam (SMMSE)
- Keywords
- Atrial Fibrillation, Plasmatic Biomarkers, ECG Monitoring
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood samples for routine analysis including NT-proBNP and plasmatic biomarkers.Diagnostic test
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).
EchocardiographyDiagnostic test
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
ECG Holter monitorDiagnostic test
Patient receives an ECG Holter for a 7-day monitoring.
Standardized Mini-Mental Status Exam (SMMSE)Diagnostic test
A screening test for evaluating cognitive performance of patients done in the clinician's office.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Peripheral blood samples for routine analysis including NT-proBNP and plasmatic biomarkers.; Diagnostic Test: Echocardiography; Diagnostic Test: ECG Holter monitor; Diagnostic Test: Standardized Mini-Mental Status Exam (SMMSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of AF
AF duration > 30s on surface ECG
Measured: Within 14 days from Inclusion.
Incidence of AF
AF duration > 30s on surface ECG
Measured: Within 14 days from Inclusion.
Secondary outcomes (8)
Cardiovascular (CV) death
Event occurred or did not occur (Yes/No).
Measured: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
All cause death
Event occurred or did not occur (Yes/No).
Measured: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
CV death + nonfatal stroke + nonfatal myocardial infarction
Event occurred or did not occur (Yes/No).
Measured: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Ischemic stroke
Event occurred or did not occur (Yes/No).
Measured: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Cognitive decline assessed by Mini-Mental State Examination
Impairment observed and recorded or not observed and not recorded (Yes/No).
Measured: Day 350-380 from inclusion (Follow-up 4) - Day 1080-1110 from inclusion (Follow-up 6)
Heart failure
Event occurred or did not occur (Yes/No). If Yes, HF classification to be indicated based on LVEF:
- with preserved LVEF (HFpEF) ii. with mid-range LVEF (HFmrEF) iii. with reduced LVEF (HFrEF)
Measured: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Hospitalization due to CV cause
Event occurred or did not occur (Yes/No).
Measured: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Acute coronary syndrome
Event occurred or did not occur (Yes/No). If Yes, type of ACS to be indicated:
- Unstable angina ii. NSTEMI iii. STEMI
Measured: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start4 Dec 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Premedix Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710745
- Sponsor's protocol ID
- 0012020
- Acronym
- AFISBIO II
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation in Relationship to Plasma Biomarkers
- ClinicalTrials.gov ID
- NCT04710745
- Acronym / sponsor ID
- AFISBIO II / 0012020
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Plasmatic Biomarkers, ECG Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Premedix AcademyUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general objective of this study is to:
- To identify novel plasmatic biomarkers associated with prevalent/incident atrial fibrillation in patients with high risk for AF and stroke.
- 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.
- 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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Peripheral blood samples for routine analysis including NT-proBNP and plasmatic biomarkers., Diagnostic Test: Echocardiography, Diagnostic Test: ECG Holter monitor, Diagnostic Test: Standardized Mini-Mental Status Exam (SMMSE)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | Study Group |
| EchocardiographyECHO 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 | Diagnostic test | Study Group |
| ECG Holter monitorPatient receives an ECG Holter for a 7-day monitoring. | Diagnostic test | Study Group |
| Standardized Mini-Mental Status Exam (SMMSE)A screening test for evaluating cognitive performance of patients done in the clinician's office. | Diagnostic test | Study Group |
Primary outcome
Prevalence of AF
Time frame: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
Incidence of AF
Time frame: Within 14 days from Inclusion.
AF duration > 30s on surface ECG
8 secondary outcomes
Cardiovascular (CV) death
Time frame: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
All cause death
Time frame: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
CV death + nonfatal stroke + nonfatal myocardial infarction
Time frame: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Ischemic stroke
Time frame: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Cognitive decline assessed by Mini-Mental State Examination
Time frame: Day 350-380 from inclusion (Follow-up 4) - Day 1080-1110 from inclusion (Follow-up 6)
Heart failure
Time frame: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Hospitalization due to CV cause
Time frame: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Acute coronary syndrome
Time frame: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Premedix Academy at 6 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan Böhm, MD, PhD, MBA, FESC (+421 907 411 499, allan.bohm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of AF (time frame: Within 14 days from Inclusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.