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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032436
Receipt No. 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

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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
Email 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
Email katotakashii@estate.ocn.ne.jp

Sponsor
Institute Gifu Prefectural General Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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