UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032186 |
|---|---|
| Receipt number | R000036662 |
| Scientific Title | Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE |
| Date of disclosure of the study information | 2018/04/16 |
| Last modified on | 2018/04/10 18:01:35 |
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Basic information
Public title
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE
Acronym
HeartFlow ADVANCE Registry
Scientific Title
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE
Scientific Title:Acronym
HeartFlow ADVANCE Registry
Region
| Japan | North America | Europe |
Condition
Condition
Coronary Artery Diseases
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes, and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (CAD), in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of the ADVANCE Registry is the reclassification rate between the coronary management plan based on the review of the cCTA compared to the management plan based on FFRCT when obtained, as assessed by an independent review committee.
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Provide written informed consent
2. Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.
Key exclusion criteria
1. cCTA showing no CAD
2. Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation
3. Any active, serious, life-threatening disease with a life expectancy of less than 1 year
4. Inability to comply with follow-up requirements
Target sample size
7500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akasaka |
Organization
Wakayama Medical University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
Kimiidera 811-1, Wakayama, Wakayama
TEL
073-447-2300
akasat@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Masui |
Organization
HeartFlow Japan
Division name
Clinical Affairs
Zip code
Address
Nishihimbashi 1-18-6, 13F, Minato, Tokyo
TEL
03-3539-3730
Homepage URL
rmasui@heartflow.com
Sponsor or person
Institute
Wakayama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
HeartFlow Inc
Organization
Division
Category of Funding Organization
Profit organization
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
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 | 04 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The enrollment requires screening and informed consent. For the enrolled subjects, 4 follow up will be made, at 90 days, 180 days, 1 year and 3 year. The follow up can be made either phone or office visit.
Management information
Registered date
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036662
