UMIN-CTR Clinical Trial

Basic information
Public title	Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in Left Anterior Descending Artery Stenosis in the Drug Eluting Stent era
Acronym	Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in LAD Artery Stenosis in the DES era
Scientific Title	Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in Left Anterior Descending Artery Stenosis in the Drug Eluting Stent era
Scientific Title:Acronym	Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in LAD Artery Stenosis in the DES era
Region	Japan

Condition
Condition	coronary artery disease
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the differences in baseline profiles and the prognosis between CAD patients with and without LAD lesions
Basic objectives2	Others
Basic objectives -Others	Prognostic comparison of each patient
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	major adverse cardiac event
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	New coronary artery disease patients
Key exclusion criteria	Patients with previously documented coronary artery disease. Patients who have undergone previous coronary revascularization.
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Yamaguchi,
Organization	Tokyo Womens Medical University
Division name	Department of Cardiology
Zip code	162-0054
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	jyamaguchi0110@gmail.com

Public contact
Name of contact person	1st name Kentaro Middle name Last name Jujo
Organization	Saitama Medical Center
Division name	Department of Cardiology
Zip code	350-8550
Address	1981 Kamoda, Kawagoe, Saitama
TEL	0492-28-3400
Homepage URL
Email	juken1123@mac.com

Sponsor
Institute	Tokyo Womens Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Womens Medical University
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
Tel	03-3353-8111
Email	juken1123@mac.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1245
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 01 Day
Date of IRB	2017 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	cohort study

Management information
Registered date	2022 Year 08 Month 05 Day
Last modified on	2022 Year 08 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055384