Cohort Study for Atrial Fibrillation Risk Stratification

An Epidemiologic, Prospective, Single Center Cohort Study for the Improvement of Atrial Fibrillation Risk Stratification in High Risk Individuals

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05442970

Acronym

AFHRI

Enrollment

3000

Registered

2022-07-05

Start date

2013-06-30

Completion date

2030-01-31

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

AFHRI is planned as a prospective, single-center cohort study in patients at high risk of AF.

Detailed description

The primary aim of the study is to evaluate and improve atrial fibrillation risk prediction, which takes into account clinical, psycho-social, environmental and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint, AF (paroxysmal or permanent).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 18 to 85 years; * Personally signed informed consent

Exclusion criteria

* Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation; * Physical or psychological incapability to cooperate in the investigations

Design outcomes

Primary

Measure	Time frame	Description
Incident atrial fibrillation	up to 4 years	12-lead Electrocardiogram (ECG) tracing, diagnosis of AF will be made if at least two cardiologists verify the rhythm abnormality using clinic visit, outside physician or hospital records, or ambulatory ECG reports.

Secondary

Measure	Time frame	Description
Myocardial infarction	up to 4 years	Typical rise and gradual fall (Troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis
Cardiovascular death	up to 4 years	if no other underlying cause of death is diagnosed: hypertension, coronary heart disease, other cardiovascular disease, atherosclerosis, diabetes mellitus, dyslipidemia, obesity, sudden death and cardiac symptoms
Heart failure	up to 4 years	echocardiography including Doppler-flow measurement

Countries

Germany

Contacts

Primary ContactRenate B Schnabel, Prof.

r.schnabel@uke.de

Backup ContactDaniel Engler, MSc.

d.engler@uke.de

Outcome results