UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of Myocardial Perfusion Linked to Infarction and Fibrosis Explored with DSCT.
Title of the study (Brief title)	AMPLIFiED
Region	Japan Asia(except Japan)

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the diagnostic performance of comprehensive cardiac CT examination including coronary CTA,dynamic CT perfusion and CT delayed enhancement in detecting hemodynamically significant coronary artery stenosis with reduced FFR.
Basic objectives2	Others
Basic objectives -Others	To assess prognostic value of comprehensive cardiac CT examination.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic performance of comprehensive cardiac CT to identify the presence of hemodynamically significant coronary stenosis with reduced FFR (<0.8)
Key secondary outcomes

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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography. 2)Able to understand and willing to sign the Informed Consent Form.
Key exclusion criteria	1)Clinically unstable (unstable angina; malignant arrhythmias; severe symptomatic heart failure -NYHA Class III or IV; known or suspected moderate or severe aortic stenosis) conditions. 2)Allergy to iodinated contrast material. 3)Reactive airway disease; Active hyperthyroidism. 4)Kidney disease (serum creatinine levels >1.5 mg/dl, HD). 5)Atrioventricular block II and III, or sick sinus syndrome. 6)ICD (pacemaker, CRT). 7)Pregnant or breastfeeding women. 8)Coronary artery intervention within the last 6 months. 9)Contraindications to beta-blockers. 10)Patients after coronar artery bypass(CABG) surgery. 11)Other inadequate conditions judged by investigators.
Target sample size	200

Research contact person
Name of lead principal investigator	Hajime Sakuma
Organization	Mie University Graduate School of Medicine
Division name	Department of Radiology
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5029
Email	sakuma@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Kakuya Kitagawa
Organization	Mie University Hospital
Division name	Department of Radiology
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5029
Homepage URL
Email	kakuya@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Radiology,Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Bayer Yakuhin
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tohoku University Hospital Kobe University Hospital Takasaki General Medical Center Peking Union University Medical Center Kagoshima Medical Center Saiseikai Matsuyama Hospital
Name of secondary funｄer(s)

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	東北大学病院（宮城県） 神戸大学医学部附属病院（兵庫県） 高崎総合医療センター（群馬県） 鹿児島医療センター（鹿児島県） 済生会松山病院（愛媛県） 北京協和医院（北京）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 09 Day
Anticipated trial start date	2015 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The AMPLIFiED trial was designed as a prospective, multicenter, trial to evaluate the diagnostic performance of comprehensive CT examination consisted of dynamic CT perfusion, coronary CT angiography and CT delayed enhancement employing invasive coronary angiography and fractional flow reserve as reference standard. This study includes 6 sites in Japan and 1 site in China.

Management information
Registered date	2015 Year 01 Month 27 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018992