UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study of FFR CT use for acute chest pain triage in the emergency department
Title of the study (Brief title)	Acute FFR CT trial
Region	Europe

Condition
Condition	Acute chest pain patients
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Superiority of FFRCT in terms of the rule-in capacity for conventional angiogram showing obstructive coronary artery disease in patients seen in the ER for acute chest pain Superiority of FFRCT in terms of the detection of significant CAD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	% of coronary angiograms showing obstructive CAD at 1 year and 3 years
Key secondary outcomes	MACE and individual components at 1 year and 3 years, cost-effectiveness, % of refused CT

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Exercise test and ECG plus coronary CT angio. If abnormal proceed to coronary angiography
Interventions/Control_2	Coronary CT angio with virtual FFR. If abnormal proceed to coronary angiography
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	Chest pain, GRACE score<140, Troponin T hs <0,052 or rise 0h-1h <0,005 mcg/l using Elecsys method, non-high risk ECG (ESC criteria)
Key exclusion criteria	no informed consent possible, limited life expectancy less than 2 years, other cardiac or non-cardiac diagnosis for chest pain, ACS, previous PCI or CABG, recent ACS within 6 months, arrhythmia, shock, acute heart failure, dynamic STT changes, contrast allergy, renal insufficiency, contra-indication to beta blockers or nitrates or adenosine, CHD
Target sample size	170

Research contact person
Name of lead principal investigator	Jeroen Sonck
Organization	UZ Brussel
Division name	Cardiology
Address	Laarbeeklaan 101, 1090 jette, Belgium
TEL	003224776009
Email	jeroen.sonck@uzbrussel.be

Public contact
Name of contact person	Ingrid Lemoine
Organization	UZ Brussel
Division name	Cardiology
Address	Laarbeeklaan 101, 1090 Jette, Belgium
TEL	003224779060
Homepage URL	http://www.chvz.be
Email	ingrid.lemoine@uzbrussel.be

Sponsor
Institute	UZ Brussel Cardiology department
Institute
Department

Funding Source
Organization	UZ Brussel cardiology and radiology department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 07 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027169