Multimodal Cardiac Imaging Registry in Patients with Atrial Fibrillation
IMAGE-AF
Multimodal, Multicentre Registry of Clinical and Imaging Data to Develop Predictive Models Based on Artificial Intelligence to Support the Diagnostic and Therapeutic Process for Patients with Atrial Fibrillation Undergoing Catheter Ablation and Cardioversion.
1 other identifier
observational
3,000
2 countries
7
Brief Summary
The goal of this observational registry is to collect a curated dataset of multimodal imaging data that will serve for development of artificial-intelligence based solutions for prediction of risk and outcomes in patients with atrial fribrillation. Type of study: observational study Study Participants: Patients with atrial fibrillation or atrial flutter who undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion. We hypothesize, that automatic analysis of video images of transthoracic echocardiography with deep learning combined with clinical data can predict the presence of left atrial appendage thrombus (LAT). Therefore, our main aim is to create and validate an artificial intelligence model to predict the presence of LAT based on automatic analysis of transthoracic echocardiography with artificial intelligence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 31, 2024
CompletedFirst Posted
Study publicly available on registry
September 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 4, 2024
August 1, 2024
2.7 years
August 31, 2024
August 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the presence of left atrial appendage thrombus in patients with atrial fibrillation or atrial flutter, in whom tranesophageal is performed before cardioversion or catheter ablation ablation.
We will asses the left atrial appendage in transesophageal echocardiography (TEEO for the presence of the left atrial appendage thrombus. During TEE we will record multiple projections of the left atrial appendage and we will measure laeft atrial appendage flows as listed below: 1. Projection on LAA (Left Atrial Appendage): 0, 45, 90, 135 degrees, and other projections that are necessary to correctly image the entire LAA according to the investigator/ echocardiographer. 2. 3D acquisition of the volume that contains LAA (multi-beat-optimized). 3. Measurement of maximum emptying velocity of LAA 1cm from the LAA ostium - at least three measurements in two different scanning angles, averaged. 4. Acquisition of spectral Doppler image of LAA emptying (three images from two or more scanning angles) (still images).
One day
Secondary Outcomes (2)
Follow up for adverse outcomes
1 year
Follow up for ablation recurrence
1 year
Other Outcomes (1)
Electroanatomical data
One Day
Study Arms (1)
AF or AFl patients
Patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period.
Interventions
Imaging data obtained with transoesophageals echocardiography will be retained as well as data from transthoracic echocardiography and from other imaging modalities, if available
Cathether ablation of atrial fibrillation substrate using one of available methods.
Eligibility Criteria
Patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period.
You may qualify if:
- \- All patients with AF or AFl in whom TEE will be performed (to assess their eligibility for cardioversion or ablation), hospitalized in a participating center during study period (all consecutive patients).
You may not qualify if:
- Age\<18, lack of informed, written consent to the TEE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University in Zielona Góralead
- Military Institute od Medicine National Research Institutecollaborator
- National Institute of Cardiology, Warsaw, Polandcollaborator
- Medical University of Silesia, Katowice, Polandcollaborator
- St. Anne's University Hospital Brno, Czech Republiccollaborator
- John Paul II Hospital, Krakowcollaborator
- Nowa Sol Multidyscyplinary Hospital, Polandcollaborator
Study Sites (7)
St. Anne Hospital
Brno, Czechia
Nowa Sol Multidyscyplinary Hospital
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Medical University of Silesia
Katowice, Poland
John Paul II Hospital
Krakow, Poland
Military Institute of Medicine National Research Institute
Warsaw, Poland
National Institute of Cardiology
Warsaw, Poland
Collegium Medicum, University of Zielona Góra
Zielona Góra, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Konrad Pieszko, MD, PhD
University of Zielona Gora
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 31, 2024
First Posted
September 4, 2024
Study Start
January 1, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
September 4, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- About 1 year after completion of the study.
We plan to release an anonymized dataset in a public repository at the end of the study. This is depending on data sharing agreements with individual sites so the final dataset may not include all participating sites or all variables.