NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1050230051

Registered date:25/06/2023

Study on Database Construction of Fainting

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedsyncope
Date of first enrollment25/06/2023
Target sample size550
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeEstablishment of a database of syncope patients
Secondary OutcomeDiagnostic 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 maximumNot applicable
Gender
Include criteria1) 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 criteriaIf the consent of the individual cannot be obtained or if the individual requests refusal to participate

Related Information

Contact

Public contact
Name Tokudome Chikako
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan Osaka Japan 564-8565
Telephone +81-661701070
E-mail tokudome.c@ncvc.go.jp
Affiliation National Cerebral and Cardiovascular Center
Scientific contact
Name Kusano Kengo
Address 6-1 Kishibe-Shimmachi, Suita, Osaka, Japan Osaka Japan 564-8565
Telephone +81-661701070
E-mail kusanokengo@ncvc.go.jp
Affiliation National Cerebral and Cardiovascular Center