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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026512
Receipt No. R000030115
Scientific Title The prospective cohort study investigating the relationship between circulating CD271-positive mononuclear cells in acute coronary syndrome and secondary coronary events
Date of disclosure of the study information 2017/04/01
Last modified on 2019/09/13

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Basic information
Public title The prospective cohort study investigating the relationship between circulating CD271-positive mononuclear cells in acute coronary syndrome and secondary coronary events
Acronym ACS-CD271 study
Scientific Title The prospective cohort study investigating the relationship between circulating CD271-positive mononuclear cells in acute coronary syndrome and secondary coronary events
Scientific Title:Acronym ACS-CD271 study
Region
Japan

Condition
Condition Acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between circulating CD271-positive mononuclear cells in acute coronary syndrome and secondary coronary events
Basic objectives2 Others
Basic objectives -Others To evaluate significance and clinical utility of quantity of CD271-positive cells in peripheral blood in acute coronary syndrome for predicting the secondary coronary events
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Progression of coronary plaque in a non-targeted lesion at between 9 and 12 months follow-up(: including total plaque capacity, plaque volume of lipid core, plaque volume of calcification, minimal thickness of fibrous cap and CT values)
Key secondary outcomes -Progression of coronary plaque in a targeted lesion after primary revascularization at between 9 and 12 months follow-up
-Revascularization at the restenotic lesion
-Coronary intervention for de-novo lesion
-Major cerebral and cardiovascular events (: cardiovascular death, non-fetal myocardial infarction, unstable angina, unexpected coronary vascularization, stroke and admission due to decompensated heart failure )

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are diagnosed with acute coronary syndrome and emergent coronary angiography and percutaneous coronary intervention are considered to be performed.
Key exclusion criteria Patients on any following conditions;
- Cardiogenic shock
- Instability of vital signs requiring a mechanical circulatory or respiratory support
- Deteriorating brady or tachy-arrhythmia
- Hemodialysis
- Allergy for iodine or anti-thrombotic drugs
- Malignancy
- Active infectious diseases

Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Takamura
Organization Kanazawa University Hospital
Division name Department of Cardiovascular Medicine
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2259
Email takashin@m-kanazawa.jp

Public contact
Name of contact person
1st name Sayaka
Middle name
Last name Kinoshita
Organization Kanazawa University
Division name Innovative Clinical Research Center
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2072
Homepage URL
Email hpsangak@adm.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization self funding
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 Innovative Clinical Research Center
Address 13-1, Takara-machi, Kanazawa
Tel 076-265-2049
Email hpsangak@adm.kanazawa-u.ac.jp

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 金沢大学附属病院(石川県)、公立松任石川中央病院(石川県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 18 Day
Date of IRB
2016 Year 05 Month 18 Day
Anticipated trial start date
2016 Year 05 Month 18 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients by whom an informed consent is obtained are enrolled and undergo the following examinations;
1. Peripheral blood collection at day 0 (before primary coronary intervention (PCI)), day 3, day 7 and at 12 months follow-up.
2. Flow cytometric analysis, Microarray analysis/quantitative PCR and ELISA are performed to examine the cell surface markers, gene expression and protein level of cytokines in peripheral blood, respectively.
3. Coronary vascular imagings: for evaluating the quantitative and qualitative character of non-targeted and targeted atherosclerotic lesions by using IVUS, OCT, OFDI or NIRS, at primary PCI and 12 months follow-up
4. Coronary CT imaging if possible.

Management information
Registered date
2017 Year 03 Month 12 Day
Last modified on
2019 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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