UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024745 |
|---|---|
| Receipt number | R000027169 |
| Scientific Title | Randomized study of FFR CT use for acute chest pain triage in the emergency department |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2017/05/24 17:38:51 |
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Basic information
Public title
Randomized study of FFR CT use for acute chest pain triage in the emergency department
Acronym
Acute FFR CT trial
Scientific Title
Randomized study of FFR CT use for acute chest pain triage in the emergency department
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Jeroen Sonck |
Organization
UZ Brussel
Division name
Cardiology
Zip code
Address
Laarbeeklaan 101, 1090 jette, Belgium
TEL
003224776009
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
http://www.chvz.be
ingrid.lemoine@uzbrussel.be
Sponsor or person
Institute
UZ Brussel Cardiology department
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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=R000027169
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
