Primary objective: To measure AF burden at population level.Secondary objective: Associate the AF burden with risk profiles in the general population.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of atrial fibrillation and AF burden score
Secondary outcome
-
Background summary
Atrial fibrillation (AF), the new cardiovascular epidemic in the 21st century,
poses significant burden to the society including patients, family and
caregivers, physicians, and healthcare systems. There is currently no measure
of AF burden at population level and the meaning and clinical interpretation of
AF burden is not clear. In this study, for the first time, will define AF
burden and its associated risk profiles in general population and will relate
this AF burden to the electro pathology and clinical risk profiles.
Study objective
Primary objective: To measure AF burden at population level.
Secondary objective: Associate the AF burden with risk profiles in the general
population.
Study design
This project will include participants of the Rotterdam Study. The Rotterdam
Study is a prospective, population-based cohort study, comprising 17,931
persons aged 40 years and over, residing in the Ommoord district of Rotterdam.
Every participant who have given informed consent will be invited every four/
five years for a follow-up visit.
2000 consecutive participants who have an appointment at the research center
for undergoing regular measurements will be eligible for receiving the ECG
sensor.
Study burden and risks
This study has a scientific purpose. Participants do not benefit directly or
personally from participation in this study. With respect to other exams
carried out within the Rotterdam Study, the policy is followed that a
participant's treating physician can request the (results of) exams any time,
if these are deemed relevant in a clinical setting. The same policy will be
followed for the current study. There is a chance that we will detect
incidental or abnormal findings and these will be reported to the participants
and their general physician using a standardize protocol (when given informed
consent).
The risk for this study includes possible skin irritation on the place where
the sensor will be attached. This is considered acceptable.
Dr. Molewaterplein 40
Roterdam 3015 GD
NL
Dr. Molewaterplein 40
Roterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Participants of the Rotterdam Study
Exclusion criteria
Participants with a pacemaker or other stimulator device
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84243.078.23 |