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Detecting and Diagnosing Atrial Fibrillation

Detecting and Diagnosing Atrial Fibrillation: enhanced case-finding in high risk patients from general practice and evaluating three ways of irregular pulse detection. A cluster randomised trial with nested diagnostic studies.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21863
Enrollment
19200
Registered
2014-11-25
Start date
2015-09-23
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Atrial fibrillation

Interventions

Randomization occurs at practice level. In the intervention practices, we perform optimized case finding. Marked patients who visit the practice are offered three index tests: pulse palpation, electr

Sponsors

Maastricht University, Maastricht Academic Medical Center (AMC) Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age of 65 years or older 2. No previously documented AF

Exclusion criteria

Exclusion criteria: 1. Having a pacemaker. 2. Legal incompetence or unable to give informed consent. 3. Suffering from terminal illness. 4. Unable to come to the practice to participate in the diagnostic process, for instance a patient who is chronically bedridden. Patients who cannot visit the practice due to a temporary situation (such as the flu) are not excluded.

Design outcomes

Primary

MeasureTime frame
(1) The difference between intervention and control practices in the number of patients with newly found AF during one year. (2) Sensitivity, specificity and other diagnostic parameters of pulse palpation, eBPM-AF and hand-ECG, respectively, using the 12-lead ECG and/or 2 week Holter monitoring as reference standard.

Secondary

MeasureTime frame
- Diagnostic test characteristics of the hand-ECG for home monitoring using the two week Holter monitoring as reference standard. - The number of patients with all index tests negative (a regular pulse with palpation and with eBPM-AF and hand-ECG not showing AF) in whom the Holter shows (paroxysmal) AF. - Description of the ‘usual care’ in the diagnostic work-up for AF (process evaluation of control practices), disclosing divergence from current guidelines. - Prevalence and incidence of (paroxysmal) AF in general practices in the Dutch general practice. - Diagnostic informativeness of patient profiles of newly detected patients with AF, including patient profiles of newly detected patients with ‘silent’ paroxysmal AF. - Comparison of the prevalence and incidence of AF between patients of Caucasian and non-Caucasian origin. - The cost effectiveness of optimized case finding (overall, and for each of the index tests separately) compared to usual care. The outcome of the analysis will be incremental costs per life year gained and per quality adjusted life year gained. - Prediction model for finding (different types of) AF.

Contacts

Public ContactN. Verbiest - van Gurp

Maastricht University

nicole.vangurp@maastrichtuniversity.nl043 388 2947

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)