Atrial Fibrillation Clinical Trial
— AFISBIO IIOfficial title:
Atrial Fibrillation in Relationship to Plasma Biomarkers
NCT number | NCT04710745 |
Other study ID # | 0012020 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 4, 2020 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Slovakia | National Institute for Cardiovascular Diseases | Bratislava | |
Slovakia | University Hospital Bratislava - Hospital of the Academician Ladislav Dérer | Bratislava | |
Slovakia | University Hospital Bratislava - Hospital Ruzinov | Bratislava | |
Slovakia | University Hospital Bratislava - Old Town Hospital | Bratislava | |
Slovakia | Hospital Malacky | Malacky | |
Slovakia | Faculty Hospital Nitra | Nitra |
Lead Sponsor | Collaborator |
---|---|
Premedix Academy |
Slovakia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of AF | AF duration > 30s on surface ECG | Within 14 days from Inclusion. | |
Primary | Incidence of AF | AF duration > 30s on surface ECG | Within 14 days from Inclusion. | |
Secondary | Cardiovascular (CV) death | Event occurred or did not occur (Yes/No). | Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6) | |
Secondary | All cause death | Event occurred or did not occur (Yes/No). | Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6) | |
Secondary | CV death + nonfatal stroke + nonfatal myocardial infarction | Event occurred or did not occur (Yes/No). | Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6) | |
Secondary | Ischemic stroke | Event occurred or did not occur (Yes/No). | Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6) | |
Secondary | Cognitive decline assessed by Mini-Mental State Examination | 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) | |
Secondary | Heart failure | 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) | |
Secondary | Hospitalization due to CV cause | Event occurred or did not occur (Yes/No). | Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6) | |
Secondary | Acute coronary syndrome | 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) |
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