UMIN-CTR Clinical Trial

Basic information
Public title	Observational prospective study to evaluate clinical significance of endothelial vasomotor function in the culprit coronary artery in patients with acute myocardial infarction
Acronym	Prospective study of coronary endothelial vasomotor function after AMI
Scientific Title	Observational prospective study to evaluate clinical significance of endothelial vasomotor function in the culprit coronary artery in patients with acute myocardial infarction
Scientific Title:Acronym	Prospective study of coronary endothelial vasomotor function after AMI
Region	Japan

Condition
Condition	Acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the effect of endothelial vasomotor function in the culprit coronary artery on ventricular function of infarcted region and TVR in patients with acute myocardial infarction
Basic objectives2	Others
Basic objectives -Others	Clinical significance of coronary endothelial vasomotor function in the culprit coronary artery in AMI patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following outcomes at 6 months and during 5.5 years after AMI will be evaluated. 1. Left ventricular function, 2. Targeted vessel revascularization in the culprit coronary artery,
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	The study patients, who admitted to Yamanashi University Hospital, met all of the following inclusion criteria; 1. Patients with acute myocardial infarction (AMI), who received emergent coronary angiography and successful reperfusion therapy by primary percutaneous coronary intervention using stent within 24 hrs after onset of AMI. 2. The culprit lesion was the proximal portion of the left anterior descending coronary artery (LAD) 3. Patients tested for endothelial vasomotor function with acetylcholine infusion in the LAD 2 weeks and 6 months after AMI
Key exclusion criteria	The study patients met any of the following exclusion criteria were excluded: 1) organic stenosis > 30% in the LAD at 2 weeks and 6 months after AMI; 2) percutaneous coronary intervention at multiple segments of the LAD; 3) in-stent and peri-stent restenosis (> 30% diameter stenosis) at the 6 month study after AMI; 4) previous percutaneous coronary intervention in the LAD before AMI; 5) previous coronary artery bypass surgery before AMI; 6) cardiovascular events during 6 months after AMI; 7) congestive heart failure; 8) persistent atrial fibrillation or a paced rhythm; 9) presence of collaterals to the LAD with Rentrop grade > 2; 10) valvular heart diseases, secondary hypertension, stroke, renal dysfunction (serum creatinine concentration > 2.0 mg/dl) or other serious diseases, 11) Left main trunk disease.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kiyotaka Middle name Last name Kugiyama
Organization	Yamanashi University Hospital
Division name	Internal Medicine II
Zip code	409-3898
Address	1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL	055-273-9590
Email	kugiyama@yamanashi.ac.jp

Public contact
Name of contact person	1st name Kiyotaka Middle name Last name Kugiyama
Organization	Yamanashi University Hospital
Division name	Internal Medicine II
Zip code	409-3898
Address	1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL	055-273-9590
Homepage URL
Email	kugiyama@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi, Department of Internal Medicine II
Institute
Department

Funding Source
Organization	University of Yamanashi, Department of Internal Medicine II
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	0552739590
Email	kugiyama@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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 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	No longer recruiting
Date of protocol fixation	2005 Year 09 Month 15 Day
Date of IRB	2006 Year 10 Month 01 Day
Anticipated trial start date	2007 Year 01 Month 10 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information	All registered patients were prospectively followed up every 2 months in the hospital or with a clinic visit for a period of up to 5.5 years.

Management information
Registered date	2015 Year 07 Month 27 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021343