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Evaluation of preventive effects of pentoxyfylline in contrast induced nephropathy in diabetic patients undergoing angioplasty

Protocol summary

Summary
To evaluate the effect of pentoxifylline on in diabetic patients undergoing angioplasty. Design: A prospective, not blinded blinded, randomized controlled trial on patients with ischemic heart diseases and diabetes who undergoing angioplasty. Setting and conduct: All patients with ischemic heart diseases and diabetes 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=45) and control (n=45). Participants: All consented patients with ischemic heart diseases and diabetes aged 18-85 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: mesurement of cystatin c before and 24 hours after PCI in each groups.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201603038307N14
Registration date: 2017-07-09, 1396/04/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-09, 1396/04/18
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
2016-06-05, 1395/03/16
Expected recruitment end date
2017-01-10, 1395/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of preventive effects of pentoxyfylline in contrast induced nephropathy in diabetic patients undergoing angioplasty
Public title
Evaluation of preventive effects of pentoxyfylline in contrast induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ischemic heart diseases and diabetic patients; age 18-85; 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 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic commite of tabriz university of medical science
Street address
golgasht
City
tabriz
Postal code
-
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
tbzmed.rec.1395.4

Health conditions studied

1

Description of health condition studied
diabetes mellitus undergoing angioplasty
ICD-10 code
E11 and I2
ICD-10 code description
diabetes mellitus and ischemic heart disease

Primary outcomes

1

Description
cystatin c
Timepoint
24 hours before and after
Method of measurement
elisa kit

Secondary outcomes

1

Description
creatinine
Timepoint
24 hours before angioplasty and after
Method of measurement
elisa kit

Intervention groups

1

Description
intervention group will recieve 1200 mg pentoxyfylline three times divided dose with standard treatments control group will only recieve standard treatments
Category
Treatment - Drugs

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
daneshgah 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
Name of organization / entity
tabriz university of medical science
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 413344798
Fax
+98 413344798
Email
tentezarimaleki@razi.tums.ac.ir
Web page address
-

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 98413344798
Fax
+98 413392593
Email
tentezari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
tabriz university of medical science
Full name of responsible person
Dr taher entezari maleki
Position
assistant professor/clinical pharmacist
Other areas of specialty/work
Street address
daneshgah street
City
tabriz
Postal code
-
Phone
+98 413392593
Fax
+98 413344798
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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