Protocol summary

Summary
Currently, the most radiopharmaceutical commonly used in the myocardial perfusion imaging are Technetium-99m based agents (99mTc- sestamibi and 99mTc- tetrofosmin) are cleared by the liver and excreted through the hepatobiliary system and cause the appearance of activity outside the heart, at liver, bile ducts and intestines. Therefore the sub-diaphragmatic activity may create false-positive and false negative results in the SPECT myocardial perfusion imaging. A total of 100 female patients referred to the nuclear medicine department of the Shahid Beheshti hospital for SPECT MPI at stress phase were randomly divided into 4 groups as follows: Group 1: no intervention; Group 2: 250 ml of water; Group 3: 250 ml of milk; Group 4: 250 ml of diluted lemon juice (100 ml lemon juice and 150 ml of water).

General information

Acronym
MPI
IRCT registration information
IRCT registration number: IRCT2015080123441N1
Registration date: 2017-11-08, 1396/08/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Seyyed Hossein Mousavie Anijdan
Name of organization / entity
Babol university of mdical siceinces
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0105
Email address
shmosavia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research department of Babol University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of the water, milk and lemon juice in the reduction of the infra-cardiac activity
Public title
The effect of different drinks on the myocardial perfusion scan
Purpose
Diagnostic
Inclusion/Exclusion criteria
Patients without previous history of cholecystectomy; liver-biliary disease; peptic ulcer; diabetes; history of myocardial infarction and heart valve disease and heart failure were enrolled in the study.
Age
From 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Mazandaran-Babol-Ganj-Afrooz Avenue
City
Babol
Postal code
47176-47745
Approval date
2015-06-02, 1394/03/12
Ethics committee reference number
IR.MUBABOL.REC.1394.29

Health conditions studied

1

Description of health condition studied
Chronic ischaemic heart disease
ICD-10 code
I25.0
ICD-10 code description
Chronic ischaemic heart disease

Primary outcomes

1

Description
Heart/liver uptake ratio
Timepoint
30 minute after driniking
Method of measurement
imaging with gamma camera

Secondary outcomes

empty

Intervention groups

1

Description
Water
Category
Other

2

Description
No intake(control)
Category
Other

3

Description
milk
Category
Other

4

Description
Lemon joiuce
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Amir Gholami
Street address
Babol-shahid sargord Ghasemi,St
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology department of Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Mazandaran-Babol - Babol University of Medical Sciences-Research and Technology department
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology department of Babol University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amir Gholami
Street address
Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amir Gholami
Position
Nuclear Medicine Specialist
Other areas of specialty/work
Street address
Babol Shahid Beheshti Hospital
City
Babol
Postal code
Phone
+98 11 3219 0105
Fax
Email
amir_gholami_4@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amir Gholami
Position
Nuclear Medicine Specialist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Babol
Postal code
Phone
+98 11 3219 0105
Fax
Email
amir_gholami_4@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amir Gholami
Position
Nuclear Medicine Specialist
Other areas of specialty/work
Street address
Nuclear Medicine Specialist
City
Babol
Postal code
Phone
+98 11 3219 0105
Fax
Email
amir_gholami_4@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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