Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT05829993
Description:
Individual participant data (IPD), including digital ECG files (.xml), pseudonymized clinical and demographic data, treatments, ECG parameters (QTc, PR, QRS, heart rate), as well as genetic and PMSI-coded data when relevant, will be shared. Data will be available after database lock and completion of the primary analysis. IPD will be transferred via a secure online platform managed by CIC-Paris Est and shared with the artificial intelligence research team at UMISCO (Dr. Edi Prifti) for scientific analysis. All data will be pseudonymized prior to transfer. Any use or transmission to third parties requires prior approval from the sponsor (AP-HP).
Study:
NCT05829993
Study Brief:
Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias