Excessive Supraventricular Activity and Atrial Fibrillation
NCT ID: NCT04593498
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2022-11-01
2028-02-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ESVEA
ESVEA (Excessive supraventricular ectopic activity): Participants with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats.
Holter recording
Holter recording with Zenicor Flex ECG during 14 days.
Echocardiography (Echo)
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
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.
24 hour ambulatory blood pressure monitoring And Arteriograph
To assess artery stiffness.
Non-ESVEA
Participants not meeting inclusion criteria
Holter recording
Holter recording with Zenicor Flex ECG during 14 days.
Echocardiography (Echo)
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
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.
24 hour ambulatory blood pressure monitoring And Arteriograph
To assess artery stiffness.
Interventions
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Holter recording
Holter recording with Zenicor Flex ECG during 14 days.
Echocardiography (Echo)
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
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.
24 hour ambulatory blood pressure monitoring And Arteriograph
To assess artery stiffness.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
70 Years
89 Years
ALL
Yes
Sponsors
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Danderyd Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Johan Engdahl
MD, Associate Professor
Locations
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Danderyd Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ESA_AF2018
Identifier Type: -
Identifier Source: org_study_id
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