UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057176 |
|---|---|
| Receipt number | R000065343 |
| Scientific Title | Thrombus aspiration in acute coronary syndrome: Pathology and OCT Correlations |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/02/28 16:47:45 |
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Basic information
Public title
Thrombus aspiration in acute coronary syndrome: Pathology and OCT Correlations
Acronym
TAPOS
Scientific Title
Thrombus aspiration in acute coronary syndrome: Pathology and OCT Correlations
Scientific Title:Acronym
TAPOS
Region
| Japan | Europe |
Condition
Condition
Acute Coronary Syndrome (ACS)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
OCT has clinically contributed to disclose the mechansm of acute coronary syndrome (ACS) including ruptured fibrous (RFC-ACS), plaque erosion (i.e. intact fibrous caps: IFC-ACS) or calcified nodule (CN-ACS). However, it has not yet been fully examined whether OCT findings coincide with in-vivo pathological analysis in ACS. To disclose the mechanism of ACS and role of macrophage phenotype, the investigators prosepectively performed OCT imaging and athero-thrombotic aspiration before PCI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is a composite of cardiovascular death, acute coronary syndrome (ACS), ischemia-driven revascularization, cardiogenic shock, and cardiac failure required hospital admission for 3 years.
Key secondary outcomes
Secondary endpoints are the individual components of the primary endpoints.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Aged >20 years, (2) a diagnosis of ACS, (3) native coronary artery lesions, (4) optical coherence tomography with sufficient quality before PCI, (5) successful thrombus aspiration with enough amount of thrombus. Recent guidelines and consensus documents indicated that routine thrombus aspiration is not recommended, but in cases of large residual thrombus burden, thrombus aspiration may be considered. Therefore, we performed athero-thrombotic aspiration only in patients who would have a merit of the aspiration procedure due to large thrombus burden.
Key exclusion criteria
(1) they have cardiogenic shock, (2) they have coronary bypass grafting (CABG), (3) they have contraindications to anticoagulation and anti-platelet therapy, (4) lesions located in tortuous vessels, in ostial segment, and in the left main stem are excluded from the study due to the difficulty in performing high-quality intracoronary imaging.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | YUKIO |
| Middle name | |
| Last name | OZAKI |
Organization
Fujita Health University School of Medicine
Division name
Cardiology
Zip code
461-0021
Address
1-98 Dengaku, Kutsukake, Toyoake, Japan 470-1192
TEL
08030713131
yukio.ozaki7@gmail.com
Public contact
Name of contact person
| 1st name | YUKIO |
| Middle name | |
| Last name | OZAKI |
Organization
Fujita Health University School of Medicine
Division name
Cardiology
Zip code
470-1192
Address
1-98 Dengaku, Kutsukake, Toyoake, Japan 470-1192
TEL
+819015609030
Homepage URL
yukio.ozaki7@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
YUKIO OZAKI
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University School of Medicine
Address
1-98 Dengaku, Kutsukake, Toyoake, Japan 470-1192
Tel
08030713131
yukio.ozaki7@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Not yet
Publication of results
Unpublished
Result
URL related to results and publications
Not yet
Number of participants that the trial has enrolled
200
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2028 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pathological analysis is performed independently without any information of clinical and OCT data at Centre for Inherited Cardiovascular Diseases, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy. The investigators compare OCT imaging analysis results, in-vivo pathological analysis results and clinical outcome without any interaction.
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065343
