Atrial Fibrillation in Relationship to Plasma Biomarkers (AFISBIO II)
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Allan Böhm, MD, PhD, MBA, FESC
- 电话号码：+421 907 411 499
- 邮箱：allan.bohm@gmail.com
学习地点
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Bratislava、斯洛伐克、813 69
- 招聘中
- University Hospital Bratislava - Old Town Hospital
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接触：
- Martin Čaprnda, MD, PhD
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首席研究员：
- Martin Čaprnda, MD, PhD
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Bratislava、斯洛伐克、826 06
- 招聘中
- University Hospital Bratislava - Hospital Ruzinov
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接触：
- Ján Páleš, MD
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首席研究员：
- Ján Páleš, MD
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Bratislava、斯洛伐克、833 05
- 招聘中
- University Hospital Bratislava - Hospital of the Academician Ladislav Dérer
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接触：
- Tereza Hlavatá, MD
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首席研究员：
- Tereza Hlavatá, MD
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Bratislava、斯洛伐克、833 48
- 招聘中
- National Institute for Cardiovascular Diseases
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接触：
- Allan Böhm, PhD, MBA, FESC
- 电话号码：+421 907 411 499
- 邮箱：allan.bohm@gmail.com
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首席研究员：
- Allan Böhm, PhD, MBA, FESC
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Malacky、斯洛伐克
- 招聘中
- Hospital Malacky
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接触：
- Tomáš Uher, MD
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首席研究员：
- Tomáš Uher, MD
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Nitra、斯洛伐克、950 01
- 招聘中
- Faculty Hospital Nitra
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接触：
- Peter Snopek, MD
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首席研究员：
- Peter Snopek, MD
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副研究员：
- Radovan Hurčík, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
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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:
Patient receives an ECG Holter for a 7-day monitoring.
A screening test for evaluating cognitive performance of patients done in the clinician's office.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of AF
大体时间：Within 14 days from Inclusion.
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AF duration > 30s on surface ECG
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Within 14 days from Inclusion.
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Incidence of AF
大体时间：Within 14 days from Inclusion.
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AF duration > 30s on surface ECG
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Within 14 days from Inclusion.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cardiovascular (CV) death
大体时间：Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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Event occurred or did not occur (Yes/No).
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Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
|
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All cause death
大体时间：Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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Event occurred or did not occur (Yes/No).
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Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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CV death + nonfatal stroke + nonfatal myocardial infarction
大体时间：Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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Event occurred or did not occur (Yes/No).
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Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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Ischemic stroke
大体时间：Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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Event occurred or did not occur (Yes/No).
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Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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Cognitive decline assessed by Mini-Mental State Examination
大体时间：Day 350-380 from inclusion (Follow-up 4) - Day 1080-1110 from inclusion (Follow-up 6)
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Impairment observed and recorded or not observed and not recorded (Yes/No).
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Day 350-380 from inclusion (Follow-up 4) - Day 1080-1110 from inclusion (Follow-up 6)
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Heart failure
大体时间：Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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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)
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Hospitalization due to CV cause
大体时间：Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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Event occurred or did not occur (Yes/No).
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Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
|
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Acute coronary syndrome
大体时间：Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
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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)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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