UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032436 |
|---|---|
| Receipt number | R000036921 |
| Scientific Title | Impact of reverse redistribution of technetium-99m-sestamibi in acute phase on improvement of left ventricular function, brain natriuretic peptide levels, exercise capacity, and prognosis in patients with acute coronary syndrome |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2020/05/02 20:08:48 |
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Basic information
Public title
Impact of reverse redistribution of technetium-99m-sestamibi in acute phase on improvement of left ventricular function, brain natriuretic peptide levels, exercise capacity, and prognosis in patients with acute coronary syndrome
Acronym
Impact of reverse redistribution of 99mTc-sestamibi in acute phase on improvement of LV function, BNP levels, exercise capacity, and prognosis in patients with ACS
Scientific Title
Impact of reverse redistribution of technetium-99m-sestamibi in acute phase on improvement of left ventricular function, brain natriuretic peptide levels, exercise capacity, and prognosis in patients with acute coronary syndrome
Scientific Title:Acronym
Impact of reverse redistribution of 99mTc-sestamibi in acute phase on improvement of LV function, BNP levels, exercise capacity, and prognosis in patients with ACS
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of reverse redistribution of 99mTc-sestamibi in acute phase on improvement of LV function, BNP levels, exercise capacity, and prognosis in patients with ACS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major cardiac events including all cause death, life-threatening arrhythmia, and heart failure requiring hospitalization
Key secondary outcomes
Improvement of LV function, BNP levels, exercise capacity in chronic phase (approximately 3 month after ACS)
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
Patients with ACS who underwent 99mTc-sestamibi myocardial perfusion imaging
Key exclusion criteria
Patients who did not undergo ultrasound echocardiography, laboratory test, and cardiopulmonary exercise test
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Noda |
Organization
Gifu Prefectural General Medical Center
Division name
Department of cardiology
Zip code
Address
Noisshiki 4-6-1, Gifu, Gifu
TEL
058-246-1111
twforest58noda@mountain.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kato |
Organization
Gifu Prefectural General Medical Center
Division name
Department of cardiology
Zip code
Address
Noisshiki 4-6-1, Gifu, Gifu
TEL
058-246-1111
Homepage URL
katotakashii@estate.ocn.ne.jp
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2018 | Year | 06 | 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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no conflict of interest.
Management information
Registered date
| 2018 | Year | 04 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036921
