UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029891
Receipt number R000034145
Scientific Title Optimization of adenosine stress for myocardial perfusion imaging.
Date of disclosure of the study information 2017/11/08
Last modified on 2023/05/17 12:07:28

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Basic information

Public title

Optimization of adenosine stress for myocardial perfusion imaging.

Acronym

Optimization of adenosine stress

Scientific Title

Optimization of adenosine stress for myocardial perfusion imaging.

Scientific Title:Acronym

Optimization of adenosine stress

Region

Japan


Condition

Condition

Ischemic heart disease

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate if accurate pharmacologic stress myocardial perfusion imaging is possible under influence of caffeine by increasing adenosine dose.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Coronary sinus blood flow according to the amount of adenosine.

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

Medicine

Interventions/Control_1

MR coronary sinus flow measurement during adenosine stress will be performed before and after intake of 166mg of caffeine. Amount of adenosine will be increased stepwise from 120 microgram/kg/min to 210 microgram/kg/min until increase of heart rate by 10 bpm or blood pressure decrease of 10 mmHg is observed. The intervention is performed only on the 1 day of MR imaging.

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

39 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy normal volunteer

Key exclusion criteria

Claustrophobia
Contraindication of adenosine including AV block
Pregnant, maternal and lactating woman

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hajime
Middle name
Last name Sakuma

Organization

Mie University Hospital

Division name

Department of Radiology

Zip code

5148507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-231-5029

Email

kakuya@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name Kakuya
Middle name
Last name Kitagawa

Organization

Mie University Hospital

Division name

Department of Radiology

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-231-5029

Homepage URL


Email

kakuya@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Hospital

Institute

Department

Personal name



Funding Source

Organization

Mie University Hospital

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

Medical Research Ethics Committee, Mie University Hospital

Address

2-174 Edobashi, Tsu, Mie, Japan

Tel

059-232-1111

Email

s-kenkyu@mo.medic.mie-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



Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 08 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

20

Results

Myocardial blood flow (MBF) during caffeine intake and restriction was evaluated using MRI. The adenosine stress was increased stepwise until an increase in heart rate of more than 10 bpm, which is a common index of stress, was achieved. The index was achieved in all subjects even when caffeine was consumed, but the number of subjects who required increased adenosine was significantly higher than when caffeine was restricted. Mean MBF was significantly lower during caffeine intake than during restriction.

Results date posted

2023 Year 05 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy volunteers (n=20, 10 females, age 30 +/- 3 years)

Participant flow

Completed the planned number of participants despite delays due to the COVID-19 pandemic.

Adverse events

No adverse events

Outcome measures

Adenosine stress will be increased stepwise under caffeine administration to evaluate whether an increase in myocardial blood flow comparable to that under caffeine restriction can be obtained.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 04 Month 08 Day

Date of IRB

2015 Year 07 Month 08 Day

Anticipated trial start date

2017 Year 12 Month 26 Day

Last follow-up date

2020 Year 12 Month 16 Day

Date of closure to data entry

2020 Year 12 Month 16 Day

Date trial data considered complete

2020 Year 12 Month 16 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 08 Day

Last modified on

2023 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034145


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name