UMIN-CTR Clinical Trial

Public title

A study on prediction of myocardial blood flow reserve using cardiac CT in patients with chronic renal failure who are undergoing hemodialysis treatment and suspected exertional angina pectoris

Acronym

Study on myocardial blood flow reserve using cardiac CT in dialysis patients

Scientific Title

A study on prediction of myocardial blood flow reserve using cardiac CT in patients with chronic renal failure who are undergoing hemodialysis treatment and suspected exertional angina pectoris

Scientific Title:Acronym

Study on myocardial blood flow reserve using cardiac CT in dialysis patients

Region

Japan

Condition

Angina pectoris

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the relevance to PCI treatment of patients who underwent MDCT examination with myocardial ischemia and correlation with FFR.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Pharmacological stress cardiac CT
Pharmacological stress myocardial perfusion scintigraphy
CAG

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Adenosine stress myocardial perfusion scintigraphy

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

30

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

A. Patients with chronic renal failure who regularly undergo dialysis treatment for more than 1 year
B. Patients who are suspected or diagnosed with angina from clinical symptoms.
C. Patients who agreed to participate in this study.

Key exclusion criteria

1. Iodine contrast agent Allergic patient
2. History of contrast agent nephropathy
3. History of multiple myeloma or organ transplantation
4. Advanced atrioventricular block
5. Signs of severe symptomatic heart failure. Determination or doubt of moderate or severe aortic valve stenosis
6. History of coronary artery bypass or other cardiac surgery
7. I have undergone coronary intervention within the past 6 months
8. Beta blocker contraindicated patients
9. Patients who are allergic to beta-blockers
10. History of bronchial stroke lung disease
11. Severe chronic obstructive pulmonary disease
12. I think that research researcher may become a problem in other medical conditions or conditions.
13. Patients who have received high dose exposure within 18 months prior to consent: more than one nuclear medicine examination or MDCT or high dose exposure of more than 50 mSv
14. Acute coronary syndrome patients
15. Contraindications to vasodilators:
Systolic blood pressure less than 90 mm Hg
Dipyridamole and the use of dipyridamole containing drugs
Use of methynolexanthin (aminophylline and caffeine)
Unstable acute myocardial infarction or acute coronary syndrome
Advanced sinus artery (<40 bpm)
16. BMI (bodymass index) 40 or more
17. Severe hepatic disorders that affect drug safety assessment, those suffering from heart disease
18. Patient judged inappropriate at the discretion of the research doctor.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yusuke Kodama

Organization

Showa University

Division name

Division of Cardiology, Department of Medicine

Zip code

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo Japan

TEL

+81-3-3784-8000

Email

y.kodama0523@gmail.com

Name of contact person

1st name
Middle name
Last name	Hiroki Tanisawa

Organization

Showa University

Division name

Division of Cardiology, Department of Medicine

Zip code

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo Japan

TEL

+81-3-3784-8000

Homepage URL

Email

tanisawa20@med.showa-u.ac.jp

Institute

Showa University

Institute

Department

Personal name

Organization

Showa University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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

2018

Year

01

Month

31

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

Preinitiation

Date of protocol fixation

2018

Year

01

Month

31

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

31

Day

Last modified on

2018

Year

01

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034814