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Randomized trial of pentoxifylline in pre-procedural cardiac injury following angioplasty in patients with ischemic heart diseases

Protocol summary

Summary
Objective: To evaluate the effect of pentoxifylline on cardiac pre-procedural injury in patients undergoing angioplasty. Design: A prospective, single blinded, randomized controlled trial on patients with ischemic heart diseases who undergoing angioplasty. Setting and conduct: All patients with ischemic heart diseases who undergoing angioplasty in Shahid Madani Hospital will be randomized (using permuted block randomization, block size 2, allocation ratio 1:1) in two groups of pentoxifylline treated (n=40) and control (n=40). Participants: All consented patients with ischemic heart diseases aged 18-80 who undergoing angioplasty and stent insertion. The exclusion criteria will include elevation of CK-MB and cTnI before PCI, history of CABG during last three months, history of previous MI, renal dysfunction (creatinine above 2.5 mg/dl), unsuccessful PCI, acute MI, cardiogenic shock, dialysis, pregnancy, inability in filling and understanding of the consent form, unconsented patients, patients who want to discontinue the study at any time. Intervention: In pentoxifylline group, all patients will be received totally 1200 mg oral pentoxifylline in three divided doses before PCI plus standard treatment. The control group will be received only standard treatment. Primary outcomes: Change of CK-MB and cTnI level before, 8, and 24 hours after PCI in each groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402068307N4
Registration date: 2014-03-10, 1392/12/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-10, 1392/12/19
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2013-12-12, 1392/09/21
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized trial of pentoxifylline in pre-procedural cardiac injury following angioplasty in patients with ischemic heart diseases
Public title
Evaluation of pentoxifylline in pre-procedural cardiac injury following angioplasty in patients with ischemic heart diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ischemic heart diseases patients; age 18-80; undergoing of angioplasty with stent insertion; filling of consent form. Exclusion Criteria: Elevation of CK-MB and cTnI before PCI; history of CABG during last three months; history of previous MI; renal dysfunction (creatinine above 2.5 mg/dl); unsuccessful PCI; acute MI; cardiogenic shock; dialysis; pregnancy; inability in filling and understanding of the consent form; unconsented patients; patients who want to discontinue the study at any time.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed using permuted block randomization with a block size of 2 and an allocation ratio of 1:1 in two groups of Pentoxifylline and control.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Committee on Medical Ethics of Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Postal code
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
92186

Health conditions studied

1

Description of health condition studied
Effect of pentoxifylline in pre-procedural cardiac injury following angioplasty in ischemic heart diseases patients
ICD-10 code
I20-I25
ICD-10 code description
Ischemic heart diseases

Primary outcomes

1

Description
CK-MB level
Timepoint
Before, 8 and 24 hours after angioplasty
Method of measurement
ELISA kits

2

Description
cTnI level
Timepoint
Before, 8 and 24 hours after angioplasty
Method of measurement
ELISA kits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: In pentoxifylline group, all patients will be received totally 1200 mg oral pentoxifylline in three divided doses before PCI plus the standard treatment.
Category
Treatment - Drugs

2

Description
Control: In the control group, patients only will be given the standard treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Heart Center of Tabriz
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Shahid Madani Heart Center, Daneshghah Street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Daneshghah street
City
Tabriz
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, Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Taher Entezari-maleki
Position
Assistant professor/ Clinical pharmacist
Other areas of specialty/work
Street address
Faculty of pharmacy, Daneshgah Street
City
Tabriz
Postal code
Phone
+98 984113392593
Fax
+98 41 1334 4798
Email
tentezari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Taher Entezari-Maleki
Position
Assistant professor/ Clinical pharmacist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Daneshghah Street
City
Tabriz
Postal code
Phone
+98 41 1339 2593
Fax
+98 41 1334 4798
Email
tentezari@gmail.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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