UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of Coronary Microvascular Dysfunction and Cardiac Function for Patients with Coronary Artery Disease Undergoing Elective Percutaneous Coronary Intervention
Acronym	Analysis of Coronary Microvascular Dysfunction After Elective Percutaneous Coronary Intervention
Scientific Title	Analysis of Coronary Microvascular Dysfunction and Cardiac Function for Patients with Coronary Artery Disease Undergoing Elective Percutaneous Coronary Intervention
Scientific Title:Acronym	Analysis of Coronary Microvascular Dysfunction After Elective Percutaneous Coronary Intervention
Region	Japan

Condition
Condition	Patients undergoing elective percutaneous coronary intervention
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the influence of coronary microvascular dysfunction and the predictor of in stent restenosis for patients undergoing percutaneous coronary intervention
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of cardiac function and the predictor of in stent restenosis after coronary intervention
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 subjects is patients with coronary artery disease undergoing percutaneous coronary intervention
Key exclusion criteria	1:Patients who are inability to give informed consent 2:Patients with dialysis 3:Patients with atrial fibrillation 4:Patients with old myocardial infection
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Koyama
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-3486
Email	jkoyama@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masatoshi Minamisawa
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-3486
Homepage URL
Email	masa1981@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Shinshu University School of Medicine
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
Address
Tel
Email

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	2013 Year 04 Month 09 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	Completed
Date of protocol fixation	2012 Year 10 Month 02 Day
Date of IRB	2012 Year 10 Month 31 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date	2022 Year 10 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Competed

Management information
Registered date	2013 Year 03 Month 28 Day
Last modified on	2022 Year 10 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012110