UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter Prospective Observational Study of Clinical Factors in Prognosis after percutaneous coronary intervention.
Acronym	A Multicenter Prospective Observational Study of Clinical Factors in Prognosis after PCI.
Scientific Title	A Multicenter Prospective Observational Study of Clinical Factors in Prognosis after percutaneous coronary intervention.
Scientific Title:Acronym	A Multicenter Prospective Observational Study of Clinical Factors in Prognosis after PCI.
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to investigate the clinical factors in prognosis after percutaneous coronary intervention.
Basic objectives2	Others
Basic objectives -Others	Evaluation and identification of clinical factors affecting long-term prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. All cause mortality 2. Cardiac death 3. Non fatal myocardial infarction 4. Heart failure 5. Repeat revascularization 6. Cerebrovascular disease 7. Peripheral artery disease
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	The study patients, who admitted to study facility, met all of the following inclusion criteria; 1. Patients undergoing percutaneous coronary intervention.
Key exclusion criteria	none
Target sample size	8000

Research contact person
Name of lead principal investigator	1st name Takeo Middle name Last name Horikoshi
Organization	University of Yamanashi
Division name	Cardiology
Zip code	409-3898
Address	1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL	055-273-9590
Email	thorikoshi@yamanashi.ac.jp

Public contact
Name of contact person	1st name Takeo Middle name Last name Horikoshi
Organization	University of Yamanashi
Division name	Cardiology
Zip code	409-3898
Address	1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL	055-273-9590
Homepage URL
Email	thorikoshi@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi, Department of Cardiology
Institute
Department

Funding Source
Organization	University of Yamanashi, Department of Cardiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Yamanashi University Hospital
Address	1110 Shimokato, Chuo City, Yamanashi Prefecture
Tel	055-273-9590
Email	asato@yamanashi.ac.jp

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	市立藤枝総合病院（静岡県） 山梨県立中央病院（山梨県） 市立甲府病院（山梨県） 甲府城南病院（山梨県） 山梨厚生病院（山梨県） 山梨大学病院(山梨県)

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 04 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	7173
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	2007 Year 04 Month 01 Day
Date of IRB	2007 Year 10 Month 01 Day
Anticipated trial start date	2008 Year 05 Month 01 Day
Last follow-up date	2021 Year 12 Month 01 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information	All registered patients were prospectively followed, as long as possible, up every 6 months in the hospital or with a clinic visit after discharge.

Management information
Registered date	2022 Year 04 Month 02 Day
Last modified on	2022 Year 04 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054027