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
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
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
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
