UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034200 |
|---|---|
| Receipt number | R000038786 |
| Scientific Title | Association with ambient temperature and plaque rupture linked by cholesterol crystal in patient with acute myocardial infarction |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2023/03/24 10:44:22 |
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Basic information
Public title
Association with ambient temperature and plaque rupture linked by cholesterol crystal in patient with acute myocardial infarction
Acronym
Ambient temperature and plaque rupture linked by cholesterol crystal
Scientific Title
Association with ambient temperature and plaque rupture linked by cholesterol crystal in patient with acute myocardial infarction
Scientific Title:Acronym
Ambient temperature and plaque rupture linked by cholesterol crystal
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the ambient temperature at the onset-time of acute myocardial infraction(AMI), distribution and 3D morphology of cholesterol crystals(CCs), and plaque rupture using 3D-optical coherence tomography (3D-OCT).
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients per ambient temperature at onset of acute myocardial infraction.
The etiology of AMI and CCs diagnosed by OCT.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study included consecutive patients with AMI who admitted to Wakayama medical university hospital between January 2016 and December 2017.
Key exclusion criteria
Cardiogenic shock, AMI occurred at non-native coronary artery, AMI caused by thromboembolism, poor OCT images, and undetermined the onset time of AMI.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanaka |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama
TEL
+81-73-441-0621
a-tanaka@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Katayama |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama
TEL
+81-73-441-0621
Homepage URL
y.katayama1229@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama
Tel
+81-73-447-2300
y.katayama1229@gmail.com
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
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S0167527320334598
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0167527320334598
Number of participants that the trial has enrolled
202
Results
The peak incidence of AMI in the winter is formed by increased plaque rupture, suggesting environmental temperature has an influence on the pathogenesis of AMI.
Results date posted
| 2023 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The number of patients with an onset of AMI across the range of ambient temperatures showed a bimodal distribution, whereas there was a single peak in delta mean daily temperature. The bimodal distribution was observed regardless of the location. The median temperature at the onset of AMI was 16.6 degree. No differences were found in the patient characteristics between the groups.
Participant flow
The participants were divided into lower and higher temperature groups according to the median value of the ambient temperature at the onset of AMI.
Adverse events
none
Outcome measures
The lower temperature group was characterized by a higher incidence of plaque rupture (lower 66% vs. higher 45%, p = .003), whereas OCT erosion was more frequent in the higher temperature group (lower 13% vs. higher 26%, p = .021). The lower temperature group showed more cholesterol crystals (lower 71% vs. higher 54%, p = .014)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We performed presentation about the part of this study at ESC 2018.
Management information
Registered date
| 2018 | Year | 09 | Month | 19 | Day |
Last modified on
| 2023 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038786
