1-Major objectives :
Evaluation of theraputic effect of folic acid on transient ischemic dilatation of diabetic patients with myocardial perfusion scan.
2-Design:
Randomized double blinded clinical trial.
3-Setting and conduct:
This is a randomized double blinded clinical trial to evaluate the effect of folic acid supplementation on TID score in myocardial perfusion scan of diabetic patients. The endocrinologist refers 40 diabetic patients which are randomly divided into two groups, one control and one case groups. Myocardial perfusion scan is then performed for all of these patients using Dipiridamole as stress agent, a sample blood is also taken from each patient on the day of MPI to assess blood Hemocysteine level , then the case group receives capsules containing 5mg of folic acid and the control group receives placebo capsules . Each patient uses one capsule a day for two months. After two months MPI and blood sampling is performed for each patient the same way as before ,TID and blood hemocysteine level of the first time are then compared with the second time.
4-Participants:
Inclusion:
Type II diabetic patients
Exclusion:
History of anti angina treatment or revascularization.
Evidence of Q wave in ECG referring to previous MI
ECG based ST changes due to ischemia
Active asthma
Type II cardiac block or more.
5-Intervention:
Allocation of folic acid or placebo randomly to the patients.
6-Main outcome measures :
Changes in TID level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120111624N1
Registration date:2013-01-02, 1391/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-02, 1391/10/13
Registrant information
Name
Mohammad Eftekhari
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
eftkhari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-10-02, 1391/07/11
Expected recruitment end date
2013-10-02, 1392/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial to evaluate the effect of folic acid supplementation on TID score in myocardial perfusion scan of diabetic patients.
Public title
Effect of folic acid on myocardial perfusion scan
Purpose
Treatment
Inclusion/Exclusion criteria
Major Inclusion criteria:
Type II diabetic patients;
Major exclusion criteria:
History of anti angina treatment or revascularization;
Evidence of Q wave in ECG referring to previous MI;
ECG based ST changes due to ischemia;
Active asthma;
Type II cardiac block or more;
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods str.Keshavarz boulevard,
City
Tehran
Postal code
Approval date
2012-10-03, 1391/07/12
Ethics committee reference number
91/د/130/1517
Health conditions studied
1
Description of health condition studied
Coronary artery disease (Atheroscelerosis)
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Myocardial perfusion
Timepoint
Before and two months after intervention
Method of measurement
MPI
Secondary outcomes
1
Description
TID
Timepoint
After MPI
Method of measurement
QPS software
2
Description
Hemocysteine blood level
Timepoint
Before MPI
Method of measurement
Blood level of hemocysteine
Intervention groups
1
Description
The intervention group receives 5mg folic acid (powdered) in capsules . 5mg folic acid (1 capsule) daily for 2 months.
Category
Treatment - Drugs
2
Description
The control group receives placebo also powdered in capsules. 1 capsule daily for 2 months.
Category
Placebo
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.Mohammad.Eftekhari
Street address
North Kargar str., Shariati hospital, Research institute for nuclear medicine
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz boulevard, Vice chancellor for Research, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for 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.Mohammad Eftekhari
Position
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
00982188633330
Phone
+98 21 8863 3330
Fax
Email
eftkhari@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research institute for nuclear medicine, Shariati street, N kargar ave.
Full name of responsible person
Dr.Mohammad Eftekhari
Position
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
00982188633330
Phone
+98 21 8863 3330
Fax
Email
eftkhari@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
Professor of Radiopharmacy
Other areas of specialty/work
Street address
Research institute for nuclear medicine, Shariati hospital, North kargar street
City
Tehran
Postal code
Phone
+98 21668333333
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)