UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054727 |
|---|---|
| Receipt number | R000062539 |
| Scientific Title | A prospective observational study to examine the role of individual natriuretic peptides forms for left ventricular remodeling in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/01/24 20:52:16 |
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Basic information
Public title
A prospective observational study to examine the role of individual natriuretic peptides forms for left ventricular remodeling in patients with acute myocardial infarction
Acronym
A prospective observational study to examine the role of individual natriuretic peptides forms for left ventricular remodeling in patients with acute myocardial infarction
Scientific Title
A prospective observational study to examine the role of individual natriuretic peptides forms for left ventricular remodeling in patients with acute myocardial infarction
Scientific Title:Acronym
A prospective observational study to examine the role of individual natriuretic peptides forms for left ventricular remodeling in patients with acute myocardial infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with first acute myocardial infarction, individual components of the natriuretic peptides will be measured using a novel developed assay, and the clinical significance of each molecule concentrations will be examined to clarify their role of post-myocardial infarction remodeling and prognosis.
Basic objectives2
Others
Basic objectives -Others
Recent studies have shown the clinical significance measuring various molecular forms of natriuretic peptides in patients with heart diseases. In this study, we will measure plasma various forms of natriuretic peptides including precursor and active forms of natriuretic peptide as well as their surrounding hormones and their downstream molecules with clinical findings in patients with first acute myocardial infarction. This integrated analysis may provide a reliable method for predicting left ventricular remodeling after acute myocardial infarction and future events based on measurements of individualized molecules in the natriuretic peptide system.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in left ventricular volume and ejection fraction from 1 year to acute phase after index acute myocardial infarction
Key secondary outcomes
major adverse cardiac and cerebrovascular events composed of all-cause death, stroke, acute coronary syndrome (ACS), hospitalization for heart failure, fatal ventricular arrhythmias, and stroke
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) onset-to-reperfusion time within 24 hours, (2) first episode of acute myocardial infarction, (3) Killip Class 1-2, (4) serum creatinine levels below 1.5 mg/dl, and (6) hemoglobin levels of 11 g/dl or more
Key exclusion criteria
(1) no reperfusion or final thrombolysis in myocardial infarction grade of 0 or 1, (2) presence of multiple organ failure, (3) occurrence of mechanical complications of AMI or refractory cardiogenic shock, (4) undergoing emergent or urgent CABG as a reperfusion therapy, (5) history of any malignancy, (6) experiencing difficulty in self-judgment due to neurological disease, mental illness, or dementia.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Yasuhide |
| Middle name | |
| Last name | Asaumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-shimmachi, Suita, Osaka
TEL
+81-6-6170-1070
asaumiya@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Yasuhide |
| Middle name | |
| Last name | Asaumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-shimmachi, Suita, Osaka
TEL
+81-6-6170-1070
Homepage URL
asaumiya@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-shimmachi, Suita, Osaka, 564-8565, Japan
Tel
81-6-6170-1070
rec-office-ac@ncvc.go.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
161
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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 25 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 25 | Day |
Other
Other related information
A prospective observational study to examine the association of left ventricular remodeling and clinical outcomes with various molecular forms of natriuretic peptides in patients with first acute myocardial infarction.
To evaluate left ventricular remodeling, enrolled patients will undergo serial echocardiogram and cardiac magnetic resonance to evaluate left ventricular volume and function at acute (10 days) and chronic phase (10-12months) after acute myocardial infarction. Blood samples for assessing plasma concentrations of various molecular forms of natriuretic peptides and their second messengers were collected at eight time points: immediately after PPCI, 12 hours after PPCI, 3 days, 5 days, 10 days 1 month 3 months and 10 months after AMI.
Clinical follow-up data, based on a standard questionnaire, were obtained through correspondence with patients, relatives, or physicians, or from hospital records.
Management information
Registered date
| 2024 | Year | 06 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062539
