UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002046
Receipt No. R000002153
Scientific Title Metabolic Syndrome Regulates the Non-Elderly or Non-Stenotic Onset in Patients with Acute Myocardial Infarction (Retrospective MAMI Study)
Date of disclosure of the study information 2009/06/08
Last modified on 2009/11/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Metabolic Syndrome Regulates the Non-Elderly or Non-Stenotic Onset in Patients with Acute Myocardial Infarction (Retrospective MAMI Study)
Acronym MetS Regulates the Onset Form of AMI.(Retrospective MAMI Study)
Scientific Title Metabolic Syndrome Regulates the Non-Elderly or Non-Stenotic Onset in Patients with Acute Myocardial Infarction (Retrospective MAMI Study)
Scientific Title:Acronym MetS Regulates the Onset Form of AMI.(Retrospective MAMI Study)
Region
Japan

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

Objectives
Narrative objectives1 To clarify the role of metabolic syndrome as a regulator of early onset or non-stenotic onset in acute myocardial infarction.
Basic objectives2 Others
Basic objectives -Others To know the way of prevention against acute myocardial infarction
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between metabolic syndrome and early or non-stenotic type onset in acute myocardial infarction
Key secondary outcomes The influence of the following other risk factors on the early or non-stenotic type onset in acute myocardial infarction; smoking, hypertension, high TC, high TG, low HDL-C, gender, HOMA index, number of diseased vessels.

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
95 years-old >
Gender Male and Female
Key inclusion criteria (1)Patients who sustained acute myocardial infarction and received usual treatment in the Division of Cardiovascular Medicine, Oita University Hospital between January 2002 and December 2006.
(2)Patients who sustained acute myocardial infarction and received usual treatment in the Cardiovascular Division in the following hospitals between January 2002 and December 2006; Oita Medical Center,Health Insurance Nankai Hospital, Oita Red Cross Hospital, and Beppu Medical Center.
(3)Patients without myocardial infarction who entered the Division of Cardiovascular Medicine of Oita University Hospital for cardiac catheterization between January 2005 and December 2008.
Key exclusion criteria Patients who did not undergo emergency coronary angiography or those who had a history of myocardial infarction.
Target sample size 430

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Hara
Organization Oita University
Division name Division of Cardiovascular Medicine
Zip code
Address 1-chome, 1-banchi, Idai-ga-oka, Hasama-machi, Yufu City, Oita
TEL 097-586-5791
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahide Hara
Organization Oita University
Division name Division of Cardiovascular Medicine
Zip code
Address 1-chome, 1-banchi, Idai-ga-oka, Hasama-machi, Yufu City, Oita
TEL 097-586-5791
Homepage URL http://www.med.oita-u.ac.jp/junkanki/
Email m-hara@med.oita-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Oita University
Institute
Department

Funding Source
Organization Division of Cardiovascular Medicine, Oita University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2009 Year 06 Month 08 Day

Related information
URL releasing protocol http://www.med.oita-u.ac.jp/junkanki/
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
2009 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information According to the clinical records, we collect following data regarding time from onset, infarct-related artery, receiving of emergency coronary angiography, operation of reperfusion therapy, reperfusion success, occurrence of slow flow phenomenon, operation of emergency coronary artery bypass grafting, serum concentration of the max creatine kinase, left ventricular ejection fraction, and in-hospital death. And the incidence of risk factors such as smoking, hypercholesterolemia, hypertriglyceridemia, low HDL-cholesterolemia, impaired glucose tolerance or diabetes, metabolic syndrome, and hypertension are also analyzed. We additionally analyze the angiographic data such as coronary occlusive form and the number of diseased vessel. We compare the background risk factors and angiographic data among the four groups (non-elderly, young-elderly, old-elderly, and the control) using univariate analysis. We divide the study patients into the non-elderly onset group and the other groups (young-elderly, old-elderly, and the control). Similarly, the patients with acute myocardial infarction are classified into the stenotic and the non-stenotic occlusion group. To clarify the regulating factors of non-elderly or non-stenotic onset of acute myocardial infarction we analyze the data using multivariate analysis.

Management information
Registered date
2009 Year 06 Month 04 Day
Last modified on
2009 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002153

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.