Het afstemmen van het risico op beroerte en op bloeding door gebruik van CHA2DS2-VASc bij behandeling van patiënten met Atrium Fibrilleren in de eerste lijn.

Balancing stroke and bleeding risk using CHA2DS2-VASc in treatment of primary care patients with Atrial Fibrillation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21810

Enrollment

Registered

2012-12-06

Start date

2013-01-01

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 Ischaemic Stroke CHA2DS2-VASc Clinical Prediction Rule Atriumfibrilleren Boezemfibrilleren Beroerte Ischaemisch CVA Klinische beslisregel

Interventions

For all consented and randomized primary care physicians, encoded information on all their AF patients will be extracted from the registry using an automated search within an already existing research

Eligibility

Inclusion criteria

Inclusion criteria: Primary care physicians affiliated with the 'Julius Huisartsen Netwerk' (JHN).

Exclusion criteria

Exclusion criteria: All physicians are eligible to participate, no exclusion criteria apply.

Design outcomes

Primary

Measure	Time frame
Primary endpoint is ischaemic stroke within two years. The possible ischaemic stroke cases that occur within the two year follow up period will all be confirmed at the end of the study by an independent adjudication committee based on all available information from the (anonymous) patient files, including letters from specialists with results from CT and/or MRI scans and information on neurological testing.	—

Measure

Time frame

Primary endpoint is ischaemic stroke within two years. The possible ischaemic stroke cases that occur within the two year follow up period will all be confirmed at the end of the study by an independent adjudication committee based on all available information from the (anonymous) patient files, including letters from specialists with results from CT and/or MRI scans and information on neurological testing.

—

Secondary

Measure	Time frame
This study has several secondary endpoints: 1. Transient ischaemic attacks in two years – defined as a transient episode of neurologic dysfunction caused by focal brain, spinal cord, or retinal ischemia, however, without cerebral infarction (no defect on CT brain) –, confirmed by an independent adjudication committee; 2. All (major and non-major) bleeding events in two years – defined by bleedings causing a fall in haemoglobin level of ≥1.24 mmol/L, or d) bleeding that require transfusion of two or more units of packed red blood cells 37 – measured by ICPC codes and specialists’ letters; 3. Conform previous studies in this field, a composite secondary endpoint of major adverse cardiac events (MACE, consisting of cardiovascular death, myocardial infarction, coronary revascularization (PCI, CABG) and cardiovascular hospitalization) within two years is also measured per patient; 4. Guideline adherence, calculated as the proportion of AF patients for each primary care physician that is threated according to the CHA2DS2-VASc score in the current international guidelines.	—

Measure

Time frame

This study has several secondary endpoints: 1. Transient ischaemic attacks in two years – defined as a transient episode of neurologic dysfunction caused by focal brain, spinal cord, or retinal ischemia, however, without cerebral infarction (no defect on CT brain) –, confirmed by an independent adjudication committee; 2. All (major and non-major) bleeding events in two years – defined by bleedings causing a fall in haemoglobin level of ≥1.24 mmol/L, or d) bleeding that require transfusion of two or more units of packed red blood cells 37 – measured by ICPC codes and specialists’ letters; 3. Conform previous studies in this field, a composite secondary endpoint of major adverse cardiac events (MACE, consisting of cardiovascular death, myocardial infarction, coronary revascularization (PCI, CABG) and cardiovascular hospitalization) within two years is also measured per patient; 4. Guideline adherence, calculated as the proportion of AF patients for each primary care physician that is threated according to the CHA2DS2-VASc score in the current international guidelines.

—

Contacts

Public ContactG.J. Geersing

Julius Center for Health Sciences and Primary Care P.O. Box 85500

G.J.Geersing@umcutrecht.nl+31 (0)88 7568181

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)