UMIN-CTR Clinical Trial

Public title

Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2

Acronym

REAL-FFRCT2

Scientific Title

Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2

Scientific Title:Acronym

REAL-FFRCT2

Region

Japan

Condition

consecutive patients who had suspected significant coronary artery disease by CCTA and undergoing invasive coronary angiography within 60 days after acquisition of CCTA

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To validate the feasibility and diagnostic performance of FFRCT in consecutive patients who had suspected significant CAD by CCTA with Nitrate spray in real clinical practice and evaluate the impact of Nitrate comparing with the diagnostic performance of FFRCT in REAL-FFRCT1

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

FFRCT value <=0.80 for suspecting hemodynamically significant CAD in FFRCT, and invasive FFR value <=0.80 as a reference standard for hemodynamically significant CAD.

Key secondary outcomes

Comparison of diagnostic performance of FFRCT between REAL-FFRCT1 and 2

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

consecutive patients who had suspected significant CAD by CCTA and undergoing invasive coronary angiography within 60 days after acquisition of CCTA

Key exclusion criteria

We excluded patients with characteristics unsuitable for CCTA, including contraindication to beta blockers, nitrates, or adenosine, advanced bradycardia, severe tachyarrhythmia, severe hypotension, severe asthma, chronic obstructive pulmonary disease, congenital heart disease, previous artificial device implantation such as pacemaker or prosthetic valve, previous percutaneous coronary intervention (PCI) with coronary stents, previous coronary artery bypass grafting, serum creatinine level greater than 1.5 mg/dL with or without hemodialysis, allergy to iodine contrast, pregnant state, acute coronary syndrome requiring emergency coronary angiography, recent myocardial infarction within 30 days before CCTA or coronary angiography, life expectancy less than 2 years, and inability to adhere to the study procedures.
However, there was no exclusion criteria for the quality of CCTA images influenced by various artifacts, such as coronary motion, opacification of coronary artery lumen by calcified plaque, and misregistration.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Takeshi Kimura

Organization

Kyoto University Graduate School of Medicine,

Division name

Department of Cardiology

Zip code

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan

TEL

075-751-4255

Email

taketaka@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tetsuma Kawaji

Organization

Kyoto University Graduate School of Medicine,

Division name

Department of Cardiology

Zip code

Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan

TEL

075-751-4255

Homepage URL

Email

kawaji@kuhp.kyoto-u.ac.jp

Institute

Department of Cardiology, Kyoto University Graduate School of Medicine,

Institute

Department

Personal name

Organization

Department of Cardiology, Kyoto University Graduate School of Medicine,

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The pre-defined endpoints of the current study were FFRCT value <=0.80 for suspecting hemodynamically significant CAD in FFRCT, and invasive FFR value <=0.80 as a reference standard for hemodynamically significant CAD. Per-vessel correlation between FFRCT and invasive FFR was assessed by Spearman`s correlation coefficients, and Bland-Altman analysis. Diagnostic performance of FFRCT was assessed by the area under the receiver operator characteristics curve (AUC) of FFRCT (<=0.80) for detecting hemodynamically significant coronary stenosis (invasive FFR<=0.80) on per-vessel basis. In AUC analysis, we adopted FFRCT value rounded off to one decimal place. Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were also evaluated.

Registered date

2016

Year

05

Month

25

Day

Last modified on

2017

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025368