UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Myocardial perfusion scintigraphy in acute myocardial infarction patients treated with successful percutaneous coronary intervention
Title of the study (Brief title)	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	Yoshihiro. J. Akashi
Organization	St.Marianna Uneversity School of Medicine
Division name	Division of cardiology,Department of Internal Medicine
Address	2-16-1 sugao , miyamae-ku , kawasaki city , kanagawa , Japan
TEL	044-977-8111
Email	nmmfy630@yahoo.co.jp

Public contact
Name of contact person	Kohei Ashikaga
Organization	St.Marianna Uneversity School of Medicine
Division name	Division of cardiology,Department of Internal Medicine
Address	2-16-1,sugao, miyamae-ku, kawasaki-city, kanagawa prefecture
TEL	044-977-8111
Homepage URL
Email	k2ashikaga@marianna-u.ac.jp

Sponsor
Institute	Division of cardiology,Department of Internal Medicine. St.Marianna Uneversity School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003303