NCT05872945

Brief Summary

LIST OF PLANNED ORIGINAL PUBLICATIONS

  1. 1.T wave inversion detection with machine learning to prevent sudden death in professional football players.
  2. 2.Machine learning applied to biological parameters for control and advisory in professional football players (Machine learning applied to biological parameters for control and advisory in professional football players.)
  3. 3.Machine learning applied to sport geolocation systems for injury prevention in professional football players.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

4.9 years

First QC Date

May 2, 2023

Last Update Submit

November 12, 2024

Conditions

Keywords

Artificial IntelligencePerformancePro Football PlayersSudden Death Prevention

Outcome Measures

Primary Outcomes (1)

  • Waves Detection

    Detection waves changes in the electrocardiogram from pro football players

    2023-2024

Interventions

ElectrocardiogramDIAGNOSTIC_TEST

Study by Artificial Intelligence the biosignal or biodata from profesional football players

Also known as: Blood Analitycs, GPS Data

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pro Football Players

You may qualify if:

  • Healthy young and professional players of legal age who play their role in professional football teams.

You may not qualify if:

  • Players who are not a regular part of these professional teams.
  • Players with known pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RCD Mallorca SAD

Palma de Mallorca, 07011, Spain

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Electrocardiogram Blood Analytics GPS Physical Data

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Adolfo Munoz Macho, Dr.

    RCD Mallorca SAD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 24, 2023

Study Start

July 1, 2019

Primary Completion

June 1, 2024

Study Completion

July 30, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

The plan is to generate an anonymous ECG, blood data and GPS Data from football players and share the dataset in XML or CSV format

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The information will be available from June 2023 onwards
Access Criteria
Information that is public and available on request to researchers with an interest in physiological datasets

Available IPD Datasets

Individual Participant Data Set Access

Locations