Skip to main content
OpenTrials
Completed

NCT Number: NCT04774341

Personalized Evidence-based Medicine in Patients With Atrial Fibrillation

A retrospective analysis

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Evgeny Pokushalov

Novosibirsk, 630090, Russia

About this study

4200 EMR of patients at high risk for stroke with 1-year follow-up will be enrolled in the current study and analyzed by clinical decision support systems (CDSS MedicBK) utilizing a core laboratory.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

EMR only if an ECG diagnosis (12-lead ECG, 24-h Holter, or other electrocardiographic documentation) confirming AF was made in patients at high risk for stroke by CHA2DS2-VASc (≥2 in men and ≥3 in women).

Exclusion criteria

No

Treatment and study plan

anticoagulation treatment

Drug

Adherence to personalized evidence-based anticoagulant treatment in patients at high risk for stroke with atrial fibrillation

Primary outcomes

  1. The percentage of guideline-based and personalized EBM recommendations

    Time frame: 1-year

    The percentage of guideline-based and personalized EBM recommendations acted on by clinicians for anticoagulant therapy in patients with AF. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-based therapy and personalized EBM therapy will be adjudicated by core laboratory.

Secondary outcomes

  1. Quantify the performance of the CDSS (MedicBK) algorithm

    Time frame: 1-year

    Quantify the performance of the CDSS (MedicBK) algorithm for presents treatment suggestions in frame of guideline-based therapy and personalized EBM therapy: the sensitivity, specificity, NPV, and PPV

  2. 1-year FU outcomes

    Time frame: 1-year

    Outcomes for all-cause mortality, thromboembolism (TE), bleeding, and the composite endpoint of any thromboembolism, cardiovascular death, or bleeding in relation to whether they were guideline-based treatment or personalized EBM treatment. Thromboembolism refers to stroke, transient ischemic attack, acute coronary syndrome, coronary intervention, cardiac arrest, peripheral embolism, and pulmonary embolism

  3. Predictors

    Time frame: 1-year

    Predictors of guideline-based and personalized EBM adherence

Sponsors and collaborators

Lead sponsor

Center of Personalized Medicine, Pirogova

Other

Collaborators

  • Center for New Medical Technologies, Novosibirsk, Russia
  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
  • I.M. Sechenov First Moscow State Medical University
  • University of Rochester

Registry information

Official study title

Personalized Evidence-based Medicine Improves Outcomes of Anticoagulation Therapy in Patients With Atrial Fibrillation

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.