UMIN-CTR Clinical Trial

Public title

Prognostic study of risk stratification among Japanese patients with chronic kidney disease and ischemic heart disease using gated myocardial perfusion SPECT

Acronym

J-ACCESS III

Scientific Title

Prognostic study of risk stratification among Japanese patients with chronic kidney disease and ischemic heart disease using gated myocardial perfusion SPECT

Scientific Title:Acronym

J-ACCESS III

Region

Japan

Condition

Chronic kidney disease, Ischemic heart disease

Classification by specialty

Cardiology	Nephrology	Radiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate whether incidence of cardiovascular event in chronic kidney disease patients with risk factors could be stratified by gated myocardial perfusion SPECT

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cardiac death, Sudden death

Key secondary outcomes

on fatal myocardial infarction,
first hospitalization for heart failure or unstable angina, stroke, coronary or peripheral revascularization.
Performed PCI or CABG, Introduce dialysis, the first event of the composite end point of a doubling of the serum creatinine concentration.

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

1) Age above 20
2) Chronic kidney disease with following A and/or B
A. Below estimated glomerular filtration(eGFR)50mL/min/1.73m2
B. Serum creatinine concentration over1.5mg/dL(Male), 1.2mg/dL(Female)
3) Patient with at least one or more following risk factors:
Hypertension, Diabetes, hyperlipidemia, Peripheral artery disease , Current smoking, Family history of coronary heart disease, history of stroke
4) Possible to SPECT study within 2 months before or after registration
5) Patients who are obtained informed consent
6) Patients with following symptom or findings but not confirmed definitive diagnosis:
A. Angina or equivalent symptoms
B. Suspected ischemic heart disease with new breath shortness or pulsation
C. Suspected ischemic heart disease by electric cardiogram

Key exclusion criteria

1) patients with dialysis or peritoneal dialysis
2) valvular disease nessesary to operation
3) HCM or DCM
4) History of myocardial infarction or angina before registration. Hiiistory of revascularization.
5) Coronary angiography or CT angiography within 2 months before registration
6) drug hypersensitivity with Tetrofosmin or analogous drug
7) Difficult to study Gated SPECT due to arrhythmias
8) Contraindication of adenosine such as spasmodic asthma
9) Unsuitable for registration by investigator

Target sample size

800

Name of lead principal investigator

1st name
Middle name
Last name	Tsunehiko Nishimura

Organization

Kyoto prefectural Medical university

Division name

Radiology

Zip code

Address

465 Kajii-machi, Kawaramachi-dori hirokoji agaru Kamigyo-ku, Kyoto city

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Cardiovascular research foundation

Division name

J-ACCESS office

Zip code

Address

1-4-1, Senri-higashimachi, Toyonaka city, Osaka

TEL

06-6155-1003

Homepage URL

Email

jimu@j-access.jp

Institute

Cardiovascular research foundation

Institute

Department

Personal name

Organization

Cardiovascular research foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

04

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2009

Year

02

Month

23

Day

Date of IRB

Anticipated trial start date

2009

Year

05

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Nishimur T, Nakajima K, et al., Prognostic study of risk stratification among Japanese patients with ischemic heart disease using gated myocardial perfusion SPECT: J-ACCESS study. Eur J Nucl Med Mol Imaging 35:319-328, 2008.
J-ACCESS study has been reported above paper including 4,031 IHD patients.
A sub-study of J-ACCESS concerning cardiovascular event with CKD patients are significantly related with MPI parameters.
MPI is the powerful tool for risk stratifying in CKD patients of cardiovascular event.
(manuscript in submission)

Registered date

2009

Year

04

Month

20

Day

Last modified on

2012

Year

04

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002298