UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002798 |
|---|---|
| Receipt number | R000003303 |
| Scientific Title | Myocardial perfusion scintigraphy in acute myocardial infarction patients treated with successful percutaneous coronary intervention |
| Date of disclosure of the study information | 2009/11/25 |
| Last modified on | 2017/01/06 09:27:31 |
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Basic information
Public title
Myocardial perfusion scintigraphy in acute myocardial infarction patients treated with successful percutaneous coronary intervention
Acronym
Myocardial perfusion scintigraphy in acute myocardial infarction patients treated with successful percutaneous coronary intervention
Scientific Title
Myocardial perfusion scintigraphy in acute myocardial infarction patients treated with successful percutaneous coronary intervention
Scientific Title:Acronym
Myocardial perfusion scintigraphy in acute myocardial infarction patients treated with successful percutaneous coronary intervention
Region
| Japan |
Condition
Condition
Acute Myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether a washout rate (WR) obtained from myocardial scintigrams predicts severity of myocardial infarction and prognosis after percutaneous coronary intervention (PCI). The effect of cardiac rehabilitation on WR was also assessed.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Hematological evaluation
Creatinine kinase (CK), CK-myoglobin binding (CK-MB), brain natriuretic peptide (BNP), creatinine (Cr)
2.Myocardial planner images
Planner images obtained in the early and delayed phase after tracer injection
3.Myocardial single photon emission computed tomography (SPECT)
Short-axis SPECT images at rest
4.Gated SPECT
Left ventricular (LV) end systolic and diastolic volumes, LV ejection fraction, LV diastolic function
Key secondary outcomes
1.Planner images in the lower
extremities (using 99mTc-MIBI)
Images in the upper and lower thighs obtained at the early phase after tracer injection
2.Cardiopulmonary exercise testing
Systolic and diastolic blood pressures at rest, at warming up, during exercise, at peak exercise and cooling down, pulse, a respiratory rates (RR), minute ventilation (VE), oxygen uptake (VO2), a carbon dioxide production rate (VCO2), the relation between ventilation and VO2 (VE/ VO2), the relation between ventilation and VCO2 (VE/VCO2), anaerobic threshold (AT), peak VO2, VE/VCO2 slope, VO2/WR, end-tidal oxygen tension pressure (PETO2), end-tidal carbon dioxide pressure (PETCO2)
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 with acute myocardial infarction confirmed by coronary angiography and those who were successfully treated with PCI in the acute phase were enrolled.
Key exclusion criteria
Patients who had acute coronary syndrome within the last half year, those with severe hepatic and/or renal impairment, those with inappropriate arrhythmia, such as premature ventricular contraction (PVC) and atrial fibrillation, for electrocardiography-gated SPECT data collection, and small heart patients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro. J. Akashi |
Organization
St.Marianna Uneversity School of Medicine
Division name
Division of cardiology,Department of Internal Medicine
Zip code
Address
2-16-1 sugao , miyamae-ku , kawasaki city , kanagawa , Japan
TEL
044-977-8111
nmmfy630@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Ashikaga |
Organization
St.Marianna Uneversity School of Medicine
Division name
Division of cardiology,Department of Internal Medicine
Zip code
Address
2-16-1,sugao, miyamae-ku, kawasaki-city, kanagawa prefecture
TEL
044-977-8111
Homepage URL
k2ashikaga@marianna-u.ac.jp
Sponsor or person
Institute
Division of cardiology,Department of Internal Medicine. St.Marianna Uneversity School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna Uneversity School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
1604
Org. issuing International ID_1
St.Marianna Uneversity School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Evaluation:
Nowadays, serum CK, CK-MB, and serum troponin are used to predict severity and prognosis in patients with acute myocardial infarction. BNP is also known as a reliable indicator of heart failure; however, BNP is not an independent prognostic indicator for severity of acute myocardial infarction. BNP levels correspond to severity of injuring in infarct area and LV diastolic function; BNP together with LVEF is useful to predict prognosis after the onset of acute myocardial infarction. Meanwhile, WR, which is obtained at the early and delayed phase after 99mTc-MIBI injection, correlates with severity of heart failure and impaired myocardium. It has been reported that WR obtained from 123I-BMIPP scintigrams has the similar results. Accordingly, WR obtained from 99mTc-MIBI scintigrams may become a predictor of severity and prognosis after treatment in acute myocardial infarction patients.
* A prospective study
* A random sample
Management information
Registered date
| 2009 | Year | 11 | Month | 25 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003303
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