UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016353 |
|---|---|
| Receipt number | R000018992 |
| Scientific Title | Assessment of Myocardial Perfusion Linked to Infarction and Fibrosis Explored with DSCT. |
| Date of disclosure of the study information | 2015/01/27 |
| Last modified on | 2019/03/08 17:10:57 |
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Basic information
Public title
Assessment of Myocardial Perfusion Linked to Infarction and Fibrosis Explored with DSCT.
Acronym
AMPLIFiED
Scientific Title
Assessment of Myocardial Perfusion Linked to Infarction and Fibrosis Explored with DSCT.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hajime Sakuma |
Organization
Mie University Graduate School of Medicine
Division name
Department of Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5029
sakuma@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kakuya Kitagawa |
Organization
Mie University Hospital
Division name
Department of Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5029
Homepage URL
kakuya@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Radiology,Mie University Graduate School of Medicine
Institute
Department
Personal name
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)
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
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 09 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018992
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
