UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024746
Receipt number R000027170
Scientific Title Prospective study of FFR CT use for the triage of ACS in the emergency department
Date of disclosure of the study information 2019/09/01
Last modified on 2017/05/24 17:43:34

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Basic information

Public title

Prospective study of FFR CT use for the triage of ACS in the emergency department

Acronym

FFR CT ACS study

Scientific Title

Prospective study of FFR CT use for the triage of ACS in the emergency department

Scientific Title:Acronym

FFR CT ACS study

Region

Europe


Condition

Condition

chest pain patients with ACS

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

accuracy of FFR CT in comparison to invasive FFR

Basic objectives2

Others

Basic objectives -Others

capacity of FFR CT to rule out normal coronary anatomy, guide revascularization

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

accuracy analysis of FFR CT (sensitivity, specificity, positive and negative predictive values and ROC analysis comparison with invasive FFR

Key secondary outcomes

% of patients where FFR CT would change upfront treatment strategy, cost effectiveness, % of non-evaluable CT


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Acute chest pain patients with high probability ACS will undergo FFR CT and then coronary angio with FFR

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

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Acute chest pain with ECG in favor of ACS, troponin T hs >0,052 or rise 0-1 hour > 0,005 ng/l using Elecsys method, GRACE score >109, no ESC criteria for urgent angio

Key exclusion criteria

no informed consent, limited life expectancy<2 years, pregnancy, other cardiac or non-cardiac diagnosis for acute chest pain, high risk ACS, previous CABG or PCI, recent ACS <6 months, arrhythmia, shock, acute heart failure, complications due to ACS, dynamic STT changes with ST elevation, contrast allergy, renal insufficiency, contra-indication to beta blockers, nitrates or adenosine, CHD

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jeroen Sonck

Organization

UZ Brussel

Division name

Cardiology

Zip code


Address

Laarbeeklaan 101, 1090 Jette, Belgium

TEL

003224776009

Email

jeroen.sonck@uzbrussel.be


Public contact

Name of contact person

1st name
Middle name
Last name Ingrid Lemoine

Organization

UZ Brussel

Division name

Cardiology

Zip code


Address

Laarbeeklaan 101, 1090 Jette, Belgium

TEL

003224779060

Homepage URL


Email

ingrid.lemoine@uzbrussel.be


Sponsor or person

Institute

UZ Brussel cardiology and radiology department

Institute

Department

Personal name



Funding Source

Organization

UZ Brussel Cardiology and radiology

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


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

UZ Brussel university hospital


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 01 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

Enrolling by invitation

Date of protocol fixation

2016 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 07 Day

Last modified on

2017 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027170


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name