UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002046 |
|---|---|
| Receipt number | 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 11:54:12 |
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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
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/
m-hara@med.oita-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Oita University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002153
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