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The image quality and myocardial to visceral uptake ratio in myocardial perfusion scan using pharmacological stress with sub-maximal exercise in comparison with pharmacological stress alone.

Protocol summary

Summary
Myocardial perfusion imaging (MPI) is a complex process, subject to a variety of artifacts and pitfalls, which may limit its clinical utility. Combining vasodilator and exercise stress reduces noncardiac side effects, may improve image quality, and enhance the detection of ischemia, compared with suboptimal exercise or vasodilator stress alone. However, data over combined protocols are limited. 98 patients (more than 20 years) with intermediate pretest probability of coronary artery disease referred for MPI with gated single-photon emission computed tomography (SPECT) will be studied. Regarding the type of stress before radiotracer injection, the patients will randomly allocated into two groups: one with 49 cases with dipyridamole stress alone (Dip) and the second (49 cases) with a combination of dipyridamole injection and a concomitant submaximal exercise (Dip-Exe). All patients will be imaged by 15th, 60th, 120th, 180th minutes after radiotracer injection. Region-of-interest (ROI) for different areas of the myocardium and viscera, i.e. right hepatic lobe and splenic curve of colon, will be drawn and visceral to myocardial activity will be analyzed in each patient.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205279881N1
Registration date: 2012-07-04, 1391/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-04, 1391/04/14
Registrant information
Name
Babak Fallahi
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3333
Email address
bfallahi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The image quality and myocardial to visceral uptake ratio in myocardial perfusion scan using pharmacological stress with sub-maximal exercise in comparison with pharmacological stress alone.
Public title
Stress effect on myocardial perfusion scan
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: age more than 20 years; non-pregnant; non-breast feeding (for female patients); intermediate pretest probability of coronary artery disease on the basis of Framingham Risk Score and Exclusion criteria: Asthma; chronic renal failure; left bundle branch block; severe AV block; Irregularly cardiac arrythmia; pacemaker; disability to perfom submaximal exercise; congestive heart failure with EF<15%; hepatic insufficiency; cholestasis; severe aortic stenosis; patient refusal to cooperate.
Age
From 20 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz boulevard, Ghods str.
City
Tehran
Postal code
Approval date
2012-05-30, 1391/03/10
Ethics committee reference number
91-01-58-9882

Health conditions studied

1

Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I20
ICD-10 code description
Angina pectoris

2

Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I24
ICD-10 code description
Other acute ischaemic heart diseases

3

Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease

Primary outcomes

1

Description
myocardial to liver activity ratio
Timepoint
15, 60, 120 and 180 minutes after radiotracer injection
Method of measurement
Reconstruction software of SPECT

2

Description
myocardial to colon (splenic curve) activity ratio
Timepoint
15, 60, 120 and 180 minutes after radiotracer injection
Method of measurement
Reconstruction software of SPECT

Secondary outcomes

empty

Intervention groups

1

Description
Interventional group: submaximal exercise upto 3 minutes at phase 1 of Bruce protocol using tredmil in addition to conventional pharmacological stress
Category
Other

2

Description
Control group: Conventional pharmacological stress alone
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Street address
Research Institute for Nuclear Medicine, Shariati Hospital, N Kargar Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Deputy of Research, Tehran University of Medical Sciences, Keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Tehran University of Medical Sciences
Proportion provided by this source
100
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
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Position
Associate Professor of Nuclear Medicine
Other areas of specialty/work
Street address
Research Institute for Nuclear Medicine, Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8863 3333
Fax
+98 21 8863 3333
Email
bfallahi@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Position
Associate Professor of Nuclear Medicine
Other areas of specialty/work
Street address
Research Institute for Nuclear Medicine, Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8863 3333
Fax
+98 21 8863 3333
Email
bfallahi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Davood Beiki
Position
Nuclear Pharmacist
Other areas of specialty/work
Street address
Research Institute for Nuclear Medicine, Shariati Hospital, North Kargar Ave.
City
Tehran
Postal code
1411713135
Phone
+98 21 8863 3333
Fax
+98 21 8802 6905
Email
beikidav@sina.tums.ac.ir
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
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