UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046643 |
|---|---|
| Receipt number | R000053070 |
| Scientific Title | A Pilot Study of Acute Coronary Syndrome Registry Project in Iwate Prefecture |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/08/14 15:44:01 |
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Basic information
Public title
A Pilot Study of Acute Coronary Syndrome Registry Project in Iwate Prefecture
Acronym
A Pilot Study of ACS Registry Project in Iwate
Scientific Title
A Pilot Study of Acute Coronary Syndrome Registry Project in Iwate Prefecture
Scientific Title:Acronym
A Pilot Study of ACS Registry Project in Iwate
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the number of cases of acute myocardial infarction in Iwate Prefecture, the clinical background of the patients, treatment details, in-hospital outcomes, and regional or inter-institutional differences in outcomes.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
(1) The treatments of acute myocardial infarction (door to balloon time in percutaneous coronary intervention, device used, final TIMI flow grade, coronary artery bypass grafting, presence of assisted circulation device, presence of ventilator).
(2) Hospitalization days and outcome at discharge (survival to discharge, death, transfer).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were hospitalized to major 11 hospitals in Iwate prefecture for acute myocardial infarction met the third universal definition (the details are listed below) between October 1, 2014 and December 31, 2018.
(1) Within 4 weeks of onset and meet under these conditions any one of the following criteria meets the diagnosis for MI:
(2) Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
i) Symptoms of ischemia.
ii) New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
iii) Development of pathological Q waves in the ECG.
iv) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
v) Identification of an intracoronary thrombus by angiography or autopsy.
vi) Cardiac death with symptoms suggestive of myocardial ischemia and presumed new ischemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased.
Key exclusion criteria
1) The patients were excluded who were admitted to the hospital with a diagnosis of acute myocardial infarction, but the final diagnosis on discharge were unstable angina pectoris, myocarditis or takotsubo cardiomyopathy.
2) Percutaneous coronary intervention or coronary artery bypass grafting related MI.
Target sample size
2453
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Itoh |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1, Yahaba-cho, Shiwa-gun, Iwate
TEL
+81-19-613-7111
tomoitoh@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Okuyama |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1, Yahaba-cho, Shiwa-gun, Iwate
TEL
+81-19-613-7111
Homepage URL
yrkoeda@iwate-med.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Iwate prefectural Chubu hospital
2) Iwate prefectural Iwai hospital
3) DIwate prefectural Isawa hospital
4) Iwate prefectural Ofunato hospital
5) Iwate prefectural Miyako hospital
6) Iwate prefectural Ninohe hospital
7) Japanese Red Cross Morioka Hospital
8) Iwate prefectural Kuji hospital
9) Iwate prefectural Kamaishi hospital
10) Iwate prefectural Chuo hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University, Research Aid Division
Address
2-1-1, Yahaba-cho, Shiwa-gun, Iwate
Tel
+81-19-613-7111
kenkyu-rinri@j.iwate-med.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
岩手医科大学附属病院 (岩手県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://iwate-heart.jp/public_information/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-23-0188/_article
Number of participants that the trial has enrolled
2453
Results
The in-hospital mortality of AMI among patients in regional general hospitals was significantly higher than among patients in high-volume hospitals. However, no significant difference in mortality rate was observed among patients with STEMI undergoing primary PCI. Although no significant difference was found in the in-hospital mortality rate of patients with Killip class I STEMI, significantly lower in-hospital mortality rates were observed in patients admitted in high-volume hospitals for Killip II-IV.
Results date posted
| 2023 | Year | 08 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
The participants were 2,453 patients with AMI admitted to hospitals in Iwate Prefecture (2014-2018).
Participant flow
Participants were assessed for clinical outcomes at discharge.
Adverse events
Because this was a retrospective observational study, no adverse events were observed.
Outcome measures
In-hospital mortality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 19 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 22 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
[Study design] Retrospective cohort study
[Subjects] Patients in Iwate Prefecture who were hospitalized and treated for acute myocardial infarction that met the third universal definition between October 1, 2014 and December 31, 2018.
[Measurement items]
(1) Physical findings (Height, weight, blood pressure, heart rate, body temperature, oxygen saturation, Killip classification), past history, laboratory data, echocardiography data, coronary angiography data on admission.
(2) The treatments of acute myocardial infarction (door to balloon time in percutaneous coronary intervention, device used, final TIMI flow grade, coronary artery bypass grafting, presence of assisted circulation device, presence of ventilator).
(3) Hospitalization days and outcome at discharge (survival to discharge, death, transfer).
Management information
Registered date
| 2022 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053070
