Status:
UNKNOWN
Atrial Fibrillation in Relationship to Plasma Biomarkers
Lead Sponsor:
Premedix Academy
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
50+ years
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...
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04710745
Start Date
December 4 2020
End Date
December 1 2024
Last Update
January 15 2021
Active Locations (6)
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1
University Hospital Bratislava - Old Town Hospital
Bratislava, Slovakia, 813 69
2
University Hospital Bratislava - Hospital Ruzinov
Bratislava, Slovakia, 826 06
3
University Hospital Bratislava - Hospital of the Academician Ladislav Dérer
Bratislava, Slovakia, 833 05
4
National Institute for Cardiovascular Diseases
Bratislava, Slovakia, 833 48