ESA-AF: Excessive Supraventricular Activity and Atrial Fibrillation
Study Details
Study Description
Brief Summary
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 and high-end echocardiography will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 2018 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 event recording (ELR). A matched control group (125 participants) without ESVEA will also be screened using same method.
Cardiovascular data from medical records will also be collected in order to attain information regarding co-morbidities and being able to assess CHA2DS2-VASC score.
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 this two time periods transthoracic echocardiography will also be preformed.
The study population will after 21± 3 months be subjected to renewed screening with ELR in order to examine the persistence of excessive supraventricular activity they will also preform a 24 hours ambulatory ECG (Holter).
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: Event loop recorder (ELR)
Echocardiography: Comprehensive transthoracic echocardiography with special focus on left atrial dimension as well as systolic and diastolic function.
Holter recording: standard 24h Holter recording Blood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months
Other Names:
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| Non-ESVEA Participants not meeting inclusion criteria |
Diagnostic Test: Event loop recorder (ELR)
Echocardiography: Comprehensive transthoracic echocardiography with special focus on left atrial dimension as well as systolic and diastolic function.
Holter recording: standard 24h Holter recording Blood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months
Other Names:
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Outcome Measures
Primary Outcome Measures
- atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA. [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.
Secondary Outcome Measures
- the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation. [2 years]
Presence of paroxysmal or permanent atrial fibrillation on follow-up ELR
- temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings. [2 years]
Comparison of burden of supraventricular extrasystolic beats and number of episodes and duration of longest episode of supraventricular tachycardia.
- temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA. [2 years]
Explorative sequential analysis of several blood biomarkers using PEA:
- association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA. [2 years]
Comparison of biomarker profile in patients diagnosed with atrial fibrillation and patients not diagnosed with atrial fibrillation.
- 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]
Long-term data on incident stroke, heart failure, major bleedning and mortality compared between ESVEA- and non-ESVEA groups.
- echocardiographic parameters in relation to ESVEA and/or AF. [2 years]
Comparison of echocardiographic parameters with focus on atrial dimension and function compared between ESVEA and non-ESVEA group.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.
Exclusion Criteria:
Age < 65 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Danderyd Hospital | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska Institutet
- Danderyd Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESA_AF2018