Evaluating the effect of Pentoxifylline on transthoracic Doppler echocardiography parameters in patients with coronary slow flow
Design
Phase 3 randomized double-blinded placebo parallel clinical trial on 48 patients. Randomization using Randomaization.com
Settings and conduct
This study will be performed on patients with slow coronary flow in the heart ward of Imam Reza Hospital in Mashhad. Patients are randomly assigned to Pentoxifylline and placebo groups. Randomization will be done using a block method with a block size of 4. The blocked randomization method is used with the volume of each block of four. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation. Due to the use of a placebo similar to the pentoxifylline, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosing slow flow of coronary arteries based on angiography results; corrected TIMI frame count of more than 27 frames per second; Age older than 18 years; Consent to admission to the study.
Not-inclusion criteria: Previous use of pentoxifylline or other methylxanthine drugs; Renal dysfunction with eGFR < 20; Hepatic dysfunction; Body mass index < 18.5; Pregnant or suspected pregnancy.
Intervention groups
Intervention group: Patients with slow coronary flow receiving common treatments along with Pentoxifylline 400 mg three times a day for one month.
Placebo group: Patients with slow coronary flow receiving common treatments along with placebo tablets three times a day for one month.
Main outcome variables
Echocardiographic parameters including: Left ventricular ejection fraction,
Left Atrial Volume Index, E/e' ratio, diastolic velocities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N19
Registration date:2024-08-03, 1403/05/13
Registration timing:prospective
Last update:2024-08-03, 1403/05/13
Update count:0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2026-08-11, 1405/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Pentoxifylline on echocardiography parameters in patients with coronary slow flow
Public title
The effect of Pentoxifylline on patients with coronary slow flow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosing slow flow of coronary arteries based on angiography results
corrected TIMI frame count of more than 27 frames per second
Age older than 18 years old
Consent to admission to the study
Exclusion criteria:
Previous use of pentoxifylline or other methylxanthine drugs
Renal dysfunction with GFR < 20
Hepatic dysfunction
Body mass index < 18.5
Pregnant or suspected pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used.
The volume of each block will be four. Then, the list of possible blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 12 blocks according to the sample size of 48. Then, random numbers between 1 and 12 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad
Echocardiographic parameters including: Left ventricular ejection fraction, Left Atrial Volume Index, E/e' ratio, diastolic velocities
Timepoint
The beginning of the study and one months later
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with slow coronary flow receiving common treatments (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with Pentoxifylline 400 mg three times a day for one month.
Category
Treatment - Drugs
2
Description
Control group: Patients with slow coronary flow receiving common treatments (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with placebo tablets three times a day for one month. Placebo will be prepared in the Pharmaceutics Laboratory of Mashhad School of Pharmacy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Cardiology, Imam Reza Hospital
Full name of responsible person
Dr. Javad Ramezani
Street address
Imam Reza hospital, Ebnsina Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
ramezanij@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@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
Dr. Behzad Senobari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza Hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
senobarib4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Behzad Senobari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
senobarib4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@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