UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026878 |
|---|---|
| Receipt number | R000030668 |
| Scientific Title | Association between Inframmatory cytokines and plaque morphology in Acute coronary syndrome |
| Date of disclosure of the study information | 2017/04/06 |
| Last modified on | 2017/04/05 18:01:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Association between Inframmatory cytokines and plaque morphology in Acute coronary syndrome
Acronym
Plaque morphology and cytokines in ACS
Scientific Title
Association between Inframmatory cytokines and plaque morphology in Acute coronary syndrome
Scientific Title:Acronym
Plaque morphology and cytokines in ACS
Region
| Japan |
Condition
Condition
Acute coronary syndrme
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inflammation is involved in the onset of acute coronary syndrome. Major mechanisms are plaque rupture and plaque erosion. To assess the plaque morphology and local inflammatory biomarkers.
Basic objectives2
Others
Basic objectives -Others
Plaque morphology is assessed by optical coherence tomography.
Coronary blood is collected with aspiration catheter.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma matrix matalloproteinase 9 andmyeloperoxidase in coronary circulation.
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Collection of 5ml coronary blood with aspiration catheter before and after stent implantation.Collection of 5ml systemic blood.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acute coronary syndrome within 6hrs from the onset
Key exclusion criteria
Hemodynamic shock
Renal insufficiency (eGFR<35ml/min/1.73m2)
Active inflammatory disease
Tortuous vessel
Referrence diameter more than 4 mm
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akasaka |
Organization
Wakayama Medical University
Division name
Cardiovascular Medicine
Zip code
Address
Kimiidera 811-1, Wakayama
TEL
073-441-0621
t-nsgc@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nishiguchi Tsuyoshi |
Organization
Wakayama Medical University
Division name
Cardiovascular Medicine
Zip code
Address
Kimiidera 811-1, Wakayama
TEL
073-441-0621
Homepage URL
t-nsgc@wakayama-med.ac.jp
Sponsor or person
Institute
Cardiovascular Medicine, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Medicine, Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://atvb.ahajournals.org/content/early/2016/09/29/ATVBAHA.116.308099.short
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2017 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030668
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
