UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006979
Receipt number R000008236
Scientific Title Significance of FFR measurements just after DES implantation for the prediction of prognosis
Date of disclosure of the study information 2012/01/01
Last modified on 2023/03/16 18:59:53

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Basic information

Public title

Significance of FFR measurements just after DES implantation for the prediction of prognosis

Acronym

The prediction of prognosis just after DES implantation

Scientific Title

Significance of FFR measurements just after DES implantation for the prediction of prognosis

Scientific Title:Acronym

The prediction of prognosis just after DES implantation

Region

Japan


Condition

Condition

stable angina pectoris, unstable angina pectoris, acute myocardial infarction, old myocardial infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the significance of FFR measurements just after DES implantation for the prediction of prognosis

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

death, myocardial infarction, cerebrovascular accident, target vessel revascularization

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients, whose FFR and pull-back intracoronary pressure were measured just after DES implantation

Key exclusion criteria

1) Patients, with DES implantation for vessels receiving collateral perfusion
2) Patients treated with 2-stents-stratery for bifurcate lesion
3) Patients, treated for same vessels that have been already implanted DES in
4) Patients, planned PCI for other vessels than DES implanted
5) Patients, post CABG
6) Patients, apparantly having cardiomyopathy

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Nobuhiro
Middle name
Last name Tanaka

Organization

Tokyo Medical University Hospital

Division name

Department of Cardiology

Zip code

1600023

Address

6-7-1Nishishinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-3342-6111

Email

n-tanaka@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Yohei
Middle name
Last name Hokama

Organization

Tokyo Medical University Hospital

Division name

Department of Cardiology

Zip code

1600023

Address

6-7-1Nishishinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-3342-6111

Homepage URL


Email

y-hokama@tokyo-med.ac.jp


Sponsor or person

Institute

Tokyo Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical University

Address

6-7-1Nishishinjuku, Shinjuku-ku, Tokyo, Japan

Tel

03-3342-6111

Email

d-somu@tokyo-med.ac.jp


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

2012 Year 01 Month 01 Day


Related information

URL releasing protocol

none

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1016/j.jjcc.2020.12.001

Number of participants that the trial has enrolled

218

Results

During follow up of 31.4months, 34 patients(16%) had cardiovascular events. Inadequate FFR group was significantly associated with higher risk of MACE. In particular, the incidence of unplanned coronary revascularization on non-target lesions was significantly higher in the inadequate FFR group.

Results date posted

2023 Year 03 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

218 patients were included in this study and were divided into two groups.
adequate FFR group (post-stent FFR is greater than 0.80, n=176) vs inadequate FFR group (post-stent FFR is 0.80 or less, n=42).

Participant flow

This study is a prospective multi-institutional research that observed consecutive cases in which FFR was measured after DES implantation during the period from September 2011 to January 2013. Totally, 218 patients were included in this study and were divided into two groups.
Group1:post-stent FFR is greater than 0.80, n=176
Group2:post-stent FFR is 0.80 or less, n=42

Adverse events

none

Outcome measures

The primary endpoint was a major adverse cardiovascular event (MACE) including cardiac death, non-fatal myocardial infarction (MI), unplanned coronary revascularization, and hospitalization for heart failure. The secondary endpoints were event rate of all-cause death, non-fatal MI, unplanned coronary revascularization, non-fatal stroke, and hospitalization for heart failure.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 01 Month 01 Day

Date of IRB

2012 Year 02 Month 29 Day

Anticipated trial start date

2012 Year 09 Month 01 Day

Last follow-up date

2018 Year 01 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 14 Day

Date trial data considered complete

2023 Year 03 Month 14 Day

Date analysis concluded

2023 Year 03 Month 14 Day


Other

Other related information

The results of this study were published in the Journal of Cardiology 77 (2021) 532-538.


Management information

Registered date

2011 Year 12 Month 28 Day

Last modified on

2023 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name