UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of FFR CT use for the triage of ACS in the emergency department
Title of the study (Brief title)	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	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
Email	ingrid.lemoine@uzbrussel.be

Sponsor
Institute	UZ Brussel cardiology and radiology department
Institute
Department

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)

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

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=R000027170