Comparison of Effectivness of Remote Ischemic Preconditioning effects(RIPC) on Contrast Induced Nephropathy in patients undergoing Coronary Angiography and Angioplasty
Effectiveness of Remote Ischemic Preconditioning in Contrast Induced Nephropathy in high risk patients
Design
100 high risk patients for contrast induced nephropathy randomized in 2 parallel groups for RIPC
Settings and conduct
Elective stable ischemic heart disease with chronic kidney disease candidate for coronary angiography and angioplasty in Rajaie Heart ceneter undergone RIPC, with protocol of 4 time cuff inflation in 5 minute about 50 mmhg upper systolic blood pressure and deflate for 5 min and 10 mmhg upper than diastolic blood pressure in control group
Participants/Inclusion and exclusion criteria
patients within 18-80 years old
Satisfaction for this study
elective stable ischemic heart disease without need for urgent angiography
high risk patients for CIN
Intervention groups
100 high risk patients for contrast induced nephropathy undergoing coronary angiography or angioplasty randomized in 2 groups with RIPC in on group and no intervention in control group
Main outcome variables
Contrast Induced Nephropathy
General information
Reason for update
Acronym
RIPC
IRCT registration information
IRCT registration number:IRCT20171230038144N1
Registration date:2018-05-20, 1397/02/30
Registration timing:retrospective
Last update:2018-05-20, 1397/02/30
Update count:0
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
Hoda Raffiei jeoldar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2078
Email address
h.b.raffiei@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-23, 1396/10/02
Expected recruitment end date
2018-02-21, 1396/12/02
Actual recruitment start date
2017-12-23, 1396/10/02
Actual recruitment end date
2018-02-21, 1396/12/02
Trial completion date
empty
Scientific title
Comparison of Effectivness of Remote Ischemic Preconditioning effects(RIPC) on Contrast Induced Nephropathy in patients undergoing Coronary Angiography and Angioplasty
Public title
Comparison of Effectivness of Remote Ischemic Preconditioning effects(RIPC) on Contrast Induced Nephropathy in patients undergoing Coronary Angiography and Angioplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with stable ischemic heart disease candidate for coronary angiography or angioplasty
chronic kidney disease
patients within 18-80 years old
Exclusion criteria:
patients unsatisfaction
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block random with Random Allow,version:1.2 software
Blinding (investigator's opinion)
Double blinded
Blinding description
Pateints with serum creatinine more than 1.4 mg/dl or glumerolar filtration rate less than 60 divided in 2 random groups with Balanced block random with Random Allow,version:1.2 software
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran Unversity of Medical Scinses
Street address
Iran University of Medical Scinsce, Hemat highway , Next to Milad Tower, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9311171014
Health conditions studied
1
Description of health condition studied
Contrast Induced Nephropathy
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
Creatinine level and Glomerular filtration rate and urinary output before coronaary angiography and angioplasty and in 3-5 days after procedure
Timepoint
before coronary angiography and angioplasty and in 3-5 days after procedure
Method of measurement
Increase 0.5mg/dl or 25% in serum creatinine levele
Secondary outcomes
empty
Intervention groups
1
Description
Elective stable ischemic heart disease with chronic kidney disease candidate for coronary angiography and angioplasty in Rajaie Heart cneter undergone RIPC,in intervention group we have with protocol of 4 time cuff inflation in 5 minute about 50 mmhg upper systolic blood pressure and deflate for 5 minute.
Category
Treatment - Devices
2
Description
Control group:In control placebo group10 mmhg upper than diastolic blood pressure in 4 time inflation and deflation in 5 minute and creatinine level and urinary output evaluate in 2-7 days after angiography
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Heart Center
Full name of responsible person
Hoda Raffiei Jelodar
Street address
Rajaee Cardiovascular, Medical and Research Center Vali Asr Ave, Nyayesh Cross Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2078
Fax
+98 21 2204 2026
Email
h.b.raffiei@rhc.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakoti
Street address
Iran University of Medical Scinsce, Hemat highway , Next to Milad Tower, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 2392 2078
Fax
+98 21 2204 2026
Email
h.b.raffiei@rhc.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hoda Raffiei jelodar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Rajaee Cardiovascular, Medical and Research Center Vali Asr Ave, Nyayesh Cross Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2078
Fax
+98 21 2204 2026
Email
h.b.raffiei@rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
HodaRaffiei Jelodar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Rajaee Cardiovascular, Medical and Research Center Vali Asr Ave, Nyayesh Cross Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2078
Fax
+98 21 2204 2026
Email
h.b.raffiei@rhc.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hoda Raffiei Jeldar
Position
Residents
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Rajaee Cardiovascular, Medical and Research Center Vali Asr Ave, Nyayesh Cross Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2078
Fax
+98 21 2204 2026
Email
h.b.raffiei@rhc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Data and analysis file would be available in SPSS format
When the data will become available and for how long
From 1397
To whom data/document is available
Physicians
Under which criteria data/document could be used
Clinical and medical management
From where data/document is obtainable
hoda raffiei jelodar
What processes are involved for a request to access data/document