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| Name | Class |
|---|---|
| Danderyd Hospital | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Non-ESVEA | Participants not meeting inclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holter recording | Diagnostic Test | Holter recording with Zenicor Flex ECG during 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA. | 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. | 10-14 days |
| Measure | Description | Time Frame |
|---|---|---|
| the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation. | Presence of paroxysmal or permanent atrial fibrillation on follow-up. | 2 years |
| Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings. |
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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 < 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
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Individuals who have underwent Holter recording at Danderyd hospital after 2022.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan Engdahl | Contact | 0046812358242 | johan.engdahl@regionstockholm.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyd Hospital | Recruiting | Stockholm | Sweden |
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20 ml of plasma will be sampled at index and at 21 months in ESVEA and control group.
| Echocardiography (Echo) | Diagnostic Test | Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function. |
|
| Blood sample | Diagnostic Test | 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 | Diagnostic Test | To assess artery stiffness. |
|
Comparison of burden of supraventricular extrasystolic beats and number of episodes and duration of longest episode of supraventricular tachycardia. |
| 2 years |
| Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA. | Explorative sequential analysis of several blood biomarkers using PEA: | 2 years |
| association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA. | Comparison of biomarker profile in patients diagnosed with atrial fibrillation and patients not diagnosed with atrial fibrillation. | 2 years |
| Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality. | Long-term data on incident stroke, heart failure, major bleedning and mortality compared between ESVEA- and non-ESVEA groups. | 4 years or longer |
| echocardiographic parameters in relation to ESVEA and/or AF. | Comparison of echocardiographic parameters with focus on atrial dimension and function compared between ESVEA and non-ESVEA group. | 2 years |
| Artrial stiffness in relation to ESVEA and/or AF. | Comparison of artrial stiffness and blood pressure | 2 yeras |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D018880 | Atrial Premature Complexes |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D059552 | Caves |
| D001800 | Blood Specimen Collection |
| D018660 | Blood Pressure Monitoring, Ambulatory |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D055593 | Geological Phenomena |
| D055585 | Physical Phenomena |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001795 | Blood Pressure Determination |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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