- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593498
Excessive Supraventricular Activity and Atrial Fibrillation (ESA-AF)
Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
Study Overview
Status
Conditions
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 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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Johan Engdahl
- Phone Number: 0046812358242
- Email: johan.engdahl@regionstockholm.se
Study Locations
-
-
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Stockholm, Sweden
- Recruiting
- Danderyd Hospital
-
Contact:
- Johan Engdahl
- Email: johan.engdahl@regionstockholm.se
-
Contact:
- Mehrnoosh Hossein beky
- Email: mehr.hossein-beky@regionstockholm.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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.
|
Holter recording with Zenicor Flex ECG during 14 days.
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
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.
To assess artery stiffness.
|
Non-ESVEA
Participants not meeting inclusion criteria
|
Holter recording with Zenicor Flex ECG during 14 days.
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
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.
To assess artery stiffness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
Time Frame: 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.
|
10-14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.
Time Frame: 2 years
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Presence of paroxysmal or permanent atrial fibrillation on follow-up.
|
2 years
|
Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.
Time Frame: 2 years
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Comparison of burden of supraventricular extrasystolic beats and number of episodes and duration of longest episode of supraventricular tachycardia.
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2 years
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Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.
Time Frame: 2 years
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Explorative sequential analysis of several blood biomarkers using PEA:
|
2 years
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association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.
Time Frame: 2 years
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Comparison of biomarker profile in patients diagnosed with atrial fibrillation and patients not diagnosed with atrial fibrillation.
|
2 years
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Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality.
Time Frame: 4 years or longer
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Long-term data on incident stroke, heart failure, major bleedning and mortality compared between ESVEA- and non-ESVEA groups.
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4 years or longer
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echocardiographic parameters in relation to ESVEA and/or AF.
Time Frame: 2 years
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Comparison of echocardiographic parameters with focus on atrial dimension and function compared between ESVEA and non-ESVEA group.
|
2 years
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Artrial stiffness in relation to ESVEA and/or AF.
Time Frame: 2 yeras
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Comparison of artrial stiffness and blood pressure
|
2 yeras
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Atrial Fibrillation
- Premature Birth
- Atrial Flutter
- Cardiac Complexes, Premature
- Atrial Premature Complexes
Other Study ID Numbers
- ESA_AF2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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