UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study to assess perioperative cardiovascular events in patients undergoing non-cardiac surgery with prior history of percutaneous coronary intervention
Acronym	Observational study for perioperative cardiovascular events in patients with patients with prior history of percutaneous coronary intervention
Scientific Title	Prospective observational study to assess perioperative cardiovascular events in patients undergoing non-cardiac surgery with prior history of percutaneous coronary intervention
Scientific Title:Acronym	Observational study for perioperative cardiovascular events in patients with patients with prior history of percutaneous coronary intervention
Region	Japan

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

Objectives
Narrative objectives1	This study is aimed to evaluate the perioperative risk of cardiovascular events and the efficacy of managements of antiplatelet therapy during non-cardiac surgery in patients with prior history of percutaneous coronary intervention.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perioperative cardiovascular events, cardiac death, myocardial infarction, and coronary revascularization, at 30 day after the surgery
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with prior history of percutaneous coronary intervention who need to undergo non-cardiac surgery or procedure
Key exclusion criteria	Patients who undergo cardiac surgery Patients who physicians determined are inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kengo Middle name Last name Tanabe
Organization	Mitsui Memorial Hospital
Division name	Division of cardiology
Zip code	1018643
Address	Kandaizumicho 1, Chiyoda-ku, Tokyo, Japan
TEL	03-3862-9111
Email	kengo-t@zd5.so-net.ne.jp

Public contact
Name of contact person	1st name Tetsu Middle name Last name Tanaka
Organization	Mitsui Memorial Hospital
Division name	Division of cardiology
Zip code	1018643
Address	Kandaizumicho 1, Chiyoda-ku, Tokyo, Japan
TEL	03-3862-9111
Homepage URL
Email	ttanaka@mitsuihosp.or.jp

Sponsor
Institute	Mitsui Memorial Hospital
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	Mitsui Memorial Hospital
Address	Kandaizumicho 1, Chiyoda-ku, Tokyo
Tel	0338629111
Email	ttanaka@mitsuihosp.or.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

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 15 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
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	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 05 Day
Date of IRB	2018 Year 07 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 16 Day
Last follow-up date	2023 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2018 Year 08 Month 12 Day
Last modified on	2020 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038459