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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
