Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
研究概览
简要总结
The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.
详细描述
Excessive supraventricular ectopic activities (ESVEA) are a common finding on long-term ECG recordings and have a connection to atrial cardiomyopathy, incident AF, stroke and mortality.
Holter recording from 2022 preformed at Danderyd hospital will be screened in order to identify 125 recordings with ESVEA, defined as at least 30 atrial ectopic beats/hour or a supraventricular run of at least 20 consecutive beats. Participants fulfilling eligibility criteria will be offered prolonged AF screening with continuous holter recording during 14 days. A matched control group (125 participants) without ESVEA will also be screened using same method.
Cardiovascular data from medical records will be collected in order to obtain information regarding co-morbidities and being able to assess CHA2DS2-VASC score. Participants will be asked to fill in a questionnaire.
Samples of blood will be collected at index time, after 21± 3 months for further analysis with the aim of identifying biomarkers for atrial fibrillation. During these two time periods echocardiography, 24 hour ambulatory blood pressure monitoring and assessment af artery stiffness with Arteriograph will also be preformed.
The study population will after 21± 3 months be subjected to renewed screening with Holter in order to examine the persistence of excessive supraventricular activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.
排除标准
- •Age < 70 years, >89 years Atrial fibrillation / flutter Lifelong treatment with oral anticoagulant Patients with implantable cardiac device Congestive heart failure (CHF) with Ejection fraction (EF) ≤ 30% Severe valvular heart disease
结局指标
主要结局
atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
时间窗: 10-14 days
Proportion of patients with at least one episode of atrial fibrillation with a duration of at least 30 seconds among patients with ESVEA on Holter recording as compared to patients without ESVEA.
次要结局
- Artrial stiffness in relation to ESVEA and/or AF.(2 yeras)
- Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.(2 years)
- the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.(2 years)
- Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.(2 years)
- association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.(2 years)
- Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality.(4 years or longer)
- echocardiographic parameters in relation to ESVEA and/or AF.(2 years)
研究者
Johan Engdahl
MD, Associate Professor
Karolinska Institutet