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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Allan Böhm, MD, PhD, MBA, FESC
- 전화번호: +421 907 411 499
- 이메일: allan.bohm@gmail.com
연구 장소
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Bratislava, 슬로바키아, 813 69
- 모병
- University Hospital Bratislava - Old Town Hospital
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연락하다:
- Martin Čaprnda, MD, PhD
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수석 연구원:
- Martin Čaprnda, MD, PhD
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Bratislava, 슬로바키아, 826 06
- 모병
- University Hospital Bratislava - Hospital Ruzinov
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연락하다:
- Ján Páleš, MD
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수석 연구원:
- Ján Páleš, MD
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Bratislava, 슬로바키아, 833 05
- 모병
- University Hospital Bratislava - Hospital of the Academician Ladislav Dérer
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연락하다:
- Tereza Hlavatá, MD
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수석 연구원:
- Tereza Hlavatá, MD
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Bratislava, 슬로바키아, 833 48
- 모병
- National Institute for Cardiovascular Diseases
-
연락하다:
- Allan Böhm, PhD, MBA, FESC
- 전화번호: +421 907 411 499
- 이메일: allan.bohm@gmail.com
-
수석 연구원:
- Allan Böhm, PhD, MBA, FESC
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Malacky, 슬로바키아
- 모병
- Hospital Malacky
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연락하다:
- Tomáš Uher, MD
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수석 연구원:
- Tomáš Uher, MD
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Nitra, 슬로바키아, 950 01
- 모병
- Faculty Hospital Nitra
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연락하다:
- Peter Snopek, MD
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수석 연구원:
- Peter Snopek, MD
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부수사관:
- Radovan Hurčík, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Prevalence of AF
기간: 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
기간: Within 14 days from Inclusion.
|
AF duration > 30s on surface ECG
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Within 14 days from Inclusion.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiovascular (CV) death
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
|
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
기간: Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
|
Event occurred or did not occur (Yes/No).
|
Day 175-205 from inclusion (Follow-up 3) - Day 1080-1110 from inclusion (Follow-up 6)
|
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Acute coronary syndrome
기간: 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)
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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