UMIN-CTR Clinical Trial

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

Acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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 )

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanazawa University

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Innovative Clinical Research Center

Address

13-1, Takara-machi, Kanazawa

Tel

076-265-2049

Email

hpsangak@adm.kanazawa-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

30

Results

Results date posted

Results Delayed

Delay expected

Results Delay Reason

The scientific paper where the results are described has not yet been published.

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer 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 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.

Registered date

2017

Year

03

Month

12

Day

Last modified on

2024

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030115