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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032186
Receipt No. 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

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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
Email 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
Email rmasui@heartflow.com

Sponsor
Institute Wakayama Medical University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036662

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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