The study has two main objectives. The first objective is to estimate the extra yield in detected cases of AF in patients aged 65 years and over, using case finding. The second is to compare three methods to detect AF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We have two primary outcomes. Firstly, we determine the difference in the
number of patients with newly found AF in intervention and control practices.
Secondly, we calculate sensitivity and specificity of pulse palpation, eBPM-AF
and hand-ECG with the 12-lead ECG as reference standard.
Secondary outcome
In addition to our primary objectives, our study will address the following
points. We will:
* investigate the diagnostic test characteristics of the hand-ECG device for
home monitoring, using the two week Holter as a reference standard.
* investigate the number of patients with a regular pulse with all index tests
negative for AF, in whom the two week Holter shows (paroxysmal) AF.
* provide real-practice data on current pathways for AF detection in Dutch
general practice (process evaluation control practices), disclosing divergence
from current guidelines.
* establish current AF prevalence and incidence figures in Dutch general
practice.
* provide patient profiles of newly detected patients with AF, including
patients with *silent* paroxysmal AF. We will also explore the differences
between patients with AF of Caucasian and non-Caucasian origin.
* develop a prediction model for finding (different types of) AF.
* determine the quality of life in patients with asymptomatic AF.
Background summary
Atrial fibrillation (AF) is an irregular heart rhythm in which electrical
signals are generated chaotically within the atria of the heart instead of the
sinus node. This causes changes in atrial blood flow, increasing the chance of
thrombus formation. The prevalence of AF is over 3.5% in people aged over 65
years. AF has important medical implications: increased mortality, reduced
quality of life and increased risk of heart failure and stroke. Adequate
antithrombotic treatment decreases the risk of stroke and death. The costs of
care for stroke rank in the top ten of most expensive diseases and comprise
over 2.2 to 4.4% of total health care costs in the Netherlands. AF is often
asymptomatic and therefore often first discovered when stroke has already
occurred. Early identification of AF could thus prevent many of these serious
and costly events.
Study objective
The study has two main objectives. The first objective is to estimate the
extra yield in detected cases of AF in patients aged 65 years and over, using
case finding. The second is to compare three methods to detect AF.
Study design
Cluster-randomized trial and nested cross-sectional diagnostic studies with
randomization at the practice level. Study duration is one year.
Intervention
In the intervention practices we perform optimized case finding. Marked
patients who visit the practice will undergo the three index tests. These tests
are pulse palpation, electronic sphygmomanometer with AF-detection (eBPM-AF)
and handheld electrocardiogram (hand-ECG). The reference standard is the
conventional 12-lead ECG. In case of a negative reading two week Holter
recording is performed to detect paroxysmal atrial fibrillation. Patients
taking home the Holter will also perform measurements with the hand-ECG at
home, three times a day. In control practices care *as usual* is delivered.
Study burden and risks
There are no risks associated with participation. In intervention practices the
burden consists of the time investment of undergoing the index and reference
tests. In all patients the pulse will be palpated and eBPM-AF and hand-ECG will
be performed. In a sample of patients a 12-lead ECG will be performed and these
patients will be asked to take a Holter recorder and a hand-ECG home for two
weeks. The Holter recorder can provoke discomfort. In control practices there
are no burdens or risks associated with participation.
Meibergdreef 15
Amsterdam 1105 AZ
NL
Meibergdreef 15
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Aged 65 and over
Not diagnosed with atrial fibrillation
Exclusion criteria
Legal incompetence
Pacemaker
Not capable of visiting the general practice
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 | NL48215.018.14 |