Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography (CIN)
Primary Purpose
Contrast Induced Nephropathy
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring coronary angiography, chronic stable angina, CIN
Eligibility Criteria
Inclusion Criteria:
- having chronic stable angina who were referred for coronary angiography
- non-pregnant female subjects
- no history of diabetes mellitus
- no history of renal failure
- no history of single kidney
- no history of cardiogenic shock
- no history of unstable angina
- no history of myocardial infarction
- no history of hypersensitivity to statins
- no history of previous intravascular contrast injection during one month before admission
Exclusion Criteria:
- glomerular filtration rate (GFR) <60
- cardiogenic shock
Sites / Locations
- Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
No Intervention
Experimental
Arm Label
placebo group
long term statin group
preoperation statin group
Arm Description
taking atorvastatin like placebo 12 hours before the procedure
taking atorvastatin for a long time before entering the study (their routine treatment)
taking atorvastatin 12 hours before the procedure
Outcomes
Primary Outcome Measures
Contrast induced nephropathy (CIN) incidence
CIN is determined as an increase in post-procedural serum creatinine of > 0.5 mg/dl or > 25% from baseline in the absence of any other causes
Secondary Outcome Measures
serum creatinine (Cr) level
Full Information
NCT ID
NCT02113540
First Posted
April 5, 2014
Last Updated
April 10, 2014
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02113540
Brief Title
Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography
Acronym
CIN
Official Title
Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
coronary angiography, chronic stable angina, CIN
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
taking atorvastatin like placebo 12 hours before the procedure
Arm Title
long term statin group
Arm Type
No Intervention
Arm Description
taking atorvastatin for a long time before entering the study (their routine treatment)
Arm Title
preoperation statin group
Arm Type
Experimental
Arm Description
taking atorvastatin 12 hours before the procedure
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Contrast induced nephropathy (CIN) incidence
Description
CIN is determined as an increase in post-procedural serum creatinine of > 0.5 mg/dl or > 25% from baseline in the absence of any other causes
Time Frame
48 hours after the procedure
Secondary Outcome Measure Information:
Title
serum creatinine (Cr) level
Time Frame
48 hours after the procedure
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
having chronic stable angina who were referred for coronary angiography
non-pregnant female subjects
no history of diabetes mellitus
no history of renal failure
no history of single kidney
no history of cardiogenic shock
no history of unstable angina
no history of myocardial infarction
no history of hypersensitivity to statins
no history of previous intravascular contrast injection during one month before admission
Exclusion Criteria:
glomerular filtration rate (GFR) <60
cardiogenic shock
Facility Information:
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
payman bidram, resident, MD
Phone
0989131102802
Email
pbidram2000@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography
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