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The efficacy of pentoxifylline in prevention of contrast-induced nephropathy in patients with myocardial infarction undergoing coronary angioplasty: A randomized clinical trial

Protocol summary

Summary
This single-blind prospective study aims to determine the efficacy of pentoxifylline in preventing contrast-induced nephropathy in patients with myocardial infarction undergoing coronary angioplasty. A total of 182 adult patients (age > 18 years) with ST elevation myocardial infarction (STMI) referred to the Department of Cardiology, Imam Reza Hospital (Mashhad, Iran) for emergency angioplasty will be recruited. The exclusion criteria will be serum creatinine more than 1.5 mg/dl, heart failure, history of end-stage renal failure or being on dialysis, use of N-acetyl cysteine, theophylline, aminoglycosides, and nonsteroidal anti-inflammatory drugs, intravenous contrast media administration within the past two days, pulmonary edema, multiple myeloma, and uncontrolled hypertension. The patients will be randomly assigned to the case and control groups (n = 91 each) using block randomization. The control group will receive routine treatment (normal saline 1-1.5 cc/kg from 6 hours before to six hours after angioplasty) without pentoxifylline (PTX). The case group will receive routine treatment plus PTX (400 mg/tid from 24 h before to 24 h after coronary angioplasty). Serum creatinine will be measured before and 2 days after the procedure. Two groups will be compared according to the occurrence of contrast-induced nephropathy within 48 hours after the procedure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014092819316N1
Registration date: 2016-07-05, 1395/04/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-05, 1395/04/15
Registrant information
Name
Pouya Nezafati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8888
Email address
nezafatip871@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2013-10-20, 1392/07/28
Expected recruitment end date
2014-07-20, 1393/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of pentoxifylline in prevention of contrast-induced nephropathy in patients with myocardial infarction undergoing coronary angioplasty: A randomized clinical trial
Public title
Effect of pentoxifylline in preventing contrast-induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Consent to participate; ST elevation myocardial infarction (STMI) and age over 18 years. Exclusion criteria: serum creatinine more than 1.5 mg/dl, heart failure; history of end-stage renal failure or being on dialysis; use of N-acetyl cysteine, theophylline, aminoglycosides, and nonsteroidal anti-inflammatory drugs; intravenous contrast media administration within the past two days; pulmonary edema; multiple myeloma; and uncontrolled hypertension
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 182
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed using block randomization method

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
IRMUMSREC139283

Health conditions studied

1

Description of health condition studied
ST elevation myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
Serum creatinine levels
Timepoint
Before angioplasty, two days after angioplasty
Method of measurement
Blood test

2

Description
Contrast-induced nephropathy
Timepoint
48 hours after angioplasty
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Normal saline (1-1.5 cc/kg from 6 hours before to 6 hours after coronary angioplasty) plus pentoxifylline (400 mg/tid from 24 h before to 24 h after coronary angioplasty).
Category
Treatment - Drugs

2

Description
Control group: Normal saline (1-1.5 cc/kg from six hours before to six hours after coronary angioplasty)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Ali Eshraghi
Street address
Imam Reza Sq., Ibn-e-Sina St.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Eslami
Street address
Daneshgah Ave.
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Eshraghi
Position
Cardiologist
Other areas of specialty/work
Street address
Department of Cardiology, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5307
Fax
Email
eshraghia@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hourak Poorzand
Position
Cardiologist
Other areas of specialty/work
Street address
Department of Cardiology, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5307
Fax
Email
poorzandh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Vejdanparast
Position
Cardiologist
Other areas of specialty/work
Street address
Department of Cardiology, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5307
Fax
Email
vejdanparast.m@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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