RAPID-AF: a novel method to detect paroxysmal atrial fibrillation in primary care and post-stroke patients with no history of AF.

Risk Assessment for Identifying Paroxysmal Atrial Fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28464

Enrollment

1000

Registered

2017-03-10

Start date

2017-04-01

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 (NL: boezemfibrilleren)

Interventions

- All included patients undergo 14-day continuous Holter monitoring, either as standard of care after ischemic stroke or TIA (post-stroke cohort) or as per inclusion into the intervention arm of the D

(2) SR with high risk of pAF, and

(3) present AF. - We compare the outcome of the SRA algorithm with the reference standard, i.e. the final outcome of conventional 14-day continuous Holter monitoring. - We assess patient satisfacti

Eligibility

Inclusion criteria

Inclusion criteria: The RAPID-AF study will be performed in two separate cohorts: (1) consecutive patients presented to the stroke unit of the department of Neurology of the Academic Medical Center (AMC), Amsterdam, and; (2) primary care patients enrolled in the intervention arm of the Detecting and Diagnosing Atrial Fibrillation (D2AF) study, a cluster randomized AF screening trial in 96 General Practices in The Netherlands (NTR No. NTR4914; ZonMw No. 839110006; METC AMC No. 2014_236). Inclusion criteria for the AMC (post-stroke) cohort: - Clinical diagnosis of ischemic stroke or TIA (acute neurological deficit with no sign of tumor or primary cerebral haemorrhage on CT-cerebrum, symptoms lasting >24h resp. 18 years - Capable of wearing 14-day Holter - Consent (written, or oral and subsequently noted in electronic health record by treating physician) for use of care data for study Inclusion criteria for the D2AF (primary care) cohort: - Age > 65 years - Family practice attendance during study period (1 year) - Written informed consent for inclusion into intervention arm of D2AF-study

Exclusion criteria

Exclusion criteria: AMC cohort: - History of atrial fibrillation (AF) - AF on admission ECG - Pacemaker and/or ICD in situ - Known life long indication for oral anticoagulants or LMWH - Life expectancy <1 year - Other probable explanation for cerebral ischemia (e.g. periprocedural ischemic stroke, carotid artery dissection) for which cardiac monitoring is not indicated D2AF cohort: - Legal incompetence or inability to provide written informed consent - History of AF - Suffering from terminal illness - Pacemaker and/or ICD

Design outcomes

Primary

Measure	Time frame
The diagnostic test characteristics of the SRA algorithm of the first 1, 2, 6, 12 and 24 hours of the Holter monitoring (sensitivity, specificity, positive and negative predictive value) for detecting pAF in both primary care patients and post-stroke patients with two weeks continuous Holter monitoring as reference standard for each patient group as well as for the complete cohort.	—

Secondary

Measure	Time frame
- Incidence of AF after 24 hours, 48 hours, 72 hours, one week and two weeks of continuous Holter monitoring in both primary care and post-stroke patients. - A prediction model for pAF including SRA results and patient variables in both primary care and post-stroke patients. - Patient satisfaction for wearing the 14-day Holter monitor.	—

Contacts

Public ContactJ.C.L. (Jelle) Himmelreich

Afdeling Huisartsgeneeskunde

j.c.himmelreich@amc.uva.nl+31 20 56 67683

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)