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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name