Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II

NCT02743416 | Unknown

• 1 other identifier: STROKESTOP II
• Study Type: observational
• Target: 6,868
• Locations: 1 country
• Sites: 1

Brief Summary

STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study.

Conditions

Atrial Fibrillation; Stroke

Keywords

Screening; Stroke prevention; Cost effectiveness

Outcome Measures

Primary Outcomes (2)

• Incidence of stroke or systemic embolism in the control group vs the intervention group

  Endpoints collected from the Swedish patient registry will be compared between the groups

  Five years

• Incidence of stroke or systemic embolism in the control group vs the low-risk group (with NT-proBNP<125 ng/L and normal index 1-lead ECG).

  Endpoints collected from the Swedish patient registry will be compared between the groups

  Five years

Secondary Outcomes (12)

• Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group

  Five years

• Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L.

  Two years

• To assess screening uptake with regards to socio-demographic factors and to study if we can improve uptake in the screening programme by decentralizing the recruitment procedure.

  Two years

• Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program.

  Five years

• Plasma and serum biomarkers and their relation to incidence of new AF and short episodes of AF (micro-AF)

  Five years

Study Arms (2)

ECG screening

Will be screened for AF using only one-stop protocol

Other: ECG screening (Zenicor-ECG) for atrial fibrillation

Control group

as per regular standard as of today

Interventions

ECG screening (Zenicor-ECG) for atrial fibrillation OTHER

Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.

ECG screening

Eligibility Criteria

• Age: 75 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals aged 75/76 residing in Stockholm will be identified using their 10-digit personal identification number. All identified subjects will be randomized in a 1:1 fashion to be invited to screening for AF or to serve as a control group. Participants with a prior diagnosis of AF will be asked if they are on treatment with anticoagulants. If they are not, a referral to cardiologist will be made to ensure appropriate treatment. Individuals without known AF will have blood samples drawn and analysed with regard to NT-proBNP using point of care analysis. All individuals with NT-proBNP\> 125 ng/L and without known AF will be taught to undergo intermittent ECG recordings twice daily for two weeks (High-risk Group). Individuals with a NT-proBNP\<125 ng/L will do one initial 1-lead ECG, and if normal not undergo further ECG screening (low-risk Group).

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Karolinska Trial Alliance, KTA Prim

Stockholm, 11361, Sweden

Location

Related Publications (2)

• Kemp Gudmundsdottir K, Svennberg E, Friberg L, Hygrell T, Frykman V, Al-Khalili F, Hijazi Z, Rosenqvist M, Engdahl J. Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year-Olds to Detect Atrial Fibrillation: STROKESTOP II. Circulation. 2024 Dec 3;150(23):1837-1846. doi: 10.1161/CIRCULATIONAHA.124.071176. Epub 2024 Sep 1.

  PMID: 39217615 DERIVED

• Fredriksson T, Gudmundsdottir KK, Frykman V, Friberg L, Al-Khalili F, Engdahl J, Svennberg E. Brief episodes of rapid irregular atrial activity (micro-AF) are a risk marker for atrial fibrillation: a prospective cohort study. BMC Cardiovasc Disord. 2020 Apr 10;20(1):167. doi: 10.1186/s12872-020-01453-w.

  PMID: 32276611 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

venous blood samples

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Mårten Rosenqvist, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)