Excessive Supraventricular Activity and Atrial Fibrillation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Holter recording, Echocardiography (Echo), Blood sample, 24 hour ambulatory blood pressure monitoring And Arteriograph.
- Кому может быть актуально
- Состояния в реестре: Atrial Fibrillation, Atrial Flutter, Supraventricular Beat, Premature, Premature Supraventricular Beats. Базовые параметры: 70 лет — 89 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
Обзор
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.
Подробное описание
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.
Four years after the completion of screening visits, data from patient records and information thorough telephone interview and/or data from Swedish Patient Register, Swedish Dispensed Drug Register will be collected
Вмешательства
- Диагностический тест Holter recording
Holter recording with Zenicor Flex ECG during 14 days. - Диагностический тест Echocardiography (Echo)
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function. - Диагностический тест Blood sample
Blood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months. Troponin T, NTproBNP, Na, K, Creatinine. Sample for Biobank for future analysis. - Диагностический тест 24 hour ambulatory blood pressure monitoring And Arteriograph
To assess artery stiffness.
Первичные конечные точки
- atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA. [Срок оценки: 10-14 days]
Вторичные конечные точки (7)
- the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation. [Срок оценки: 2 years]
- Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings. [Срок оценки: 2 years]
- Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA. [Срок оценки: 2 years]
- association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA. [Срок оценки: 2 years]
- Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality. [Срок оценки: 4 years or longer]
- echocardiographic parameters in relation to ESVEA and/or AF. [Срок оценки: 2 years]
- Artrial stiffness in relation to ESVEA and/or AF. [Срок оценки: 2 yeras]
Критерии участия
Критерии включения
Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.
Критерии исключения
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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швеция · 1 центр
- Danderyd Hospital — Stockholm
Идентификаторы
NCT: NCT04593498 · ESA_AF2018