Study on Database Construction of Fainting

JRCT ID: jRCT1050230051

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: syncope
• Date of first enrollment: 25/06/2023
• Target sample size: 550
• Study type: Observational

Outcome(s)

• Primary Outcome: Establishment of a database of syncope patients

Secondary Outcome

Diagnostic flowchart of TLOC cases, including the rate of confirmed diagnosis (and the rate of unexplained deaths)
Rates of sudden death and the period from the date of initial visit to the sudden death.
Rate of repeated syncope after the initial visit (if yes, whether or not there was an injury at the time of syncope)
Rates of invasive interventions (e.g., implantable cardiac devices, catheterization, or surgery)
Total number of tests performed to reach a definitive diagnosis (including ILR)
Percentage of treatment modalities (lifestyle guidance, drug therapy, catheter/device therapy, etc.) for syncope
The number of patients with syncope who received treatment for syncope (including ILR). The period from the date of the first visit (defined as the date of the first visit to the clinic as syncope) to the date of definitive diagnosis.
The number of tests performed before ILR implantation and the period from the date of the first visit to the date of ILR implantation.
The rate of definitive diagnosis by ILR and the time from ILR implantation to definitive diagnosis
Differences in positive predictive value and time required for data extraction/analysis among ILR manufacturers.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

1) Patients 18 years of age or older who visited our hospital for syncope between April 1, 2022 and December 31, 2025.
2) Patients whose "syncope template" is recorded by the attending physician in the medical record of the National Cerebral and Cardiovascular Center.

• Exclude criteria: If the consent of the individual cannot be obtained or if the individual requests refusal to participate

Related Information

• Primary Sponsor: Kengo Kusano