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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018434
Receipt No. R000021343
Scientific Title Observational prospective study to evaluate clinical significance of endothelial vasomotor function in the culprit coronary artery in patients with acute myocardial infarction
Date of disclosure of the study information 2015/08/01
Last modified on 2019/07/30

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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/ctr_e/ctr_view.cgi?recptno=R000021343

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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