Evaluation of effect of oral pentoxifylline in reducing chest pain in patients with slow flow coronary arteries
Design
The clinical trial will be performed on a group of 40 patients with Coronary slow flow in coronary angiography . After 2 weeks they will be evaluated by a questionnaire about severity, frequency and duration of chest pain. If chest pain continues, they will be treated with pentoxifylline for 2 weeks more and will be evaluated again for the same parameters.
Settings and conduct
location of study: cardiology ward of Imam Reza hospital in Mashhad.
population of study: patient with coronary slow flow in coronary angiography with more than 30 years old.
blinding of study: no blinding was done
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients with slow flow coronary arteries in angiography; patients at the age of 30 years old and over.
Non-inclusion criteria:
ejection fraction less than thirty percent; allergy to pentoxifylline; creatinine clearance less than 30; severe mitral stenosis; severe aortic stenosis
Intervention groups
Patients with slow flow coronary arteries in angiography will be treated with standard medicine .If chest pain is sustained, they will undergo treatment with Pentoxifylline.
Main outcome variables
Severity of chest pain based on Likert scale; frequency of chest pain; duration of chest pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210711051842N1
Registration date:2022-04-30, 1401/02/10
Registration timing:registered_while_recruiting
Last update:2022-04-30, 1401/02/10
Update count:0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Reza Teimouri dastjerdan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 9747
Email address
teimouridr971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral pentoxifylline on reducing chest pain in ischemic patients with slow flow coronary arteries
Public title
Effect of pentoxifylline in treatment of patients with slow flow coronary arteries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with slow flow coronary arteries in angiography
Exclusion criteria:
Age more than thirty years
Creatinine clearance less than 30
Severe aortic stenosis
Severe mitral stenosis
Age
From 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
First floor; No.44, Haft-e-tir 15; Haft-e-tir Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178854453
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.229
Health conditions studied
1
Description of health condition studied
Pentoxifylline in patients with slow flow coronary arteries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of chest pain through Likert scale
Timepoint
Evaluation of chest pain after angiography and after two weeks and one month
Method of measurement
Questionnarie for evaluating severity,frequency and duration of chest pain
Secondary outcomes
1
Description
frequency chest pain
Timepoint
at the time of angiography and two weeks and one month later
Method of measurement
Questionnaire usage
2
Description
duration of chest pain
Timepoint
at the time of angiography and two weeks and one month later
Method of measurement
Questionnaire usage
3
Description
severity of chest pain based on Canadian cardiovascular society score (CCS)
Timepoint
at the time of angiography and two weeks and one month later
Method of measurement
Questionnaire usage
Intervention groups
1
Description
Intervention group: patients with slow flow coronary arteries in angiography will be treated with standard medicine for two weeks and in case of pain continuation, will be treated with oral pentoxifylline 400 milligram three times a day for two weeks and finally pentoxifylline effect in chest pain reduction will be evaluated.( the same questionnaire will be filled two weeks and one month after coronary angiography by the same person)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital in Mashhad
Full name of responsible person
Reza Teimouri Dastjerdan
Street address
First floor; No.44, Haft-e-tir 15; Haft-e-tir Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178854453
Phone
+98 51 3867 9747
Email
teinouridr971@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahid Ghayur Mobarhan
Street address
First floor; No.44, Haft-e-tir 15; Haft-e-tir Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178854453
Phone
+98 51 3867 9747
Email
teimouridr971@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Teimouri Dastjerdan
Position
cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
First floor; No.44, Haft-e-tir 15; Haft-e-tir Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178854453
Phone
+98 51 3867 9747
Email
teimouridr971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Teimouri Dastjerdan
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
First floor; No.44, Haft-e-tir 15; Haft-e-tir Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178854453
Phone
+98 51 3867 9747
Email
teimouridr971@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Teimouri Dastjerdan
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
First floor; No.44, Haft-e-tir 15; Haft-e-tir Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178854453
Phone
+98 51 3867 9747
Email
teinouridr971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available