Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02113540

Collaborator

(none)

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Drug: Atorvastatin	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo group taking atorvastatin like placebo 12 hours before the procedure
No Intervention: long term statin group taking atorvastatin for a long time before entering the study (their routine treatment)
Experimental: preoperation statin group taking atorvastatin 12 hours before the procedure	Drug: Atorvastatin

Arm

Intervention/Treatment

Placebo Comparator: placebo group

taking atorvastatin like placebo 12 hours before the procedure

No Intervention: long term statin group

taking atorvastatin for a long time before entering the study (their routine treatment)

Experimental: preoperation statin group

taking atorvastatin 12 hours before the procedure

Drug: Atorvastatin

Outcome Measures

Primary Outcome Measures

Contrast induced nephropathy (CIN) incidence [48 hours after the procedure]
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 [48 hours after the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Isfahan		Iran, Islamic Republic of

Sponsors and Collaborators

Isfahan University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

peyman bidram, Dr peyman bidram, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02113540

Other Study ID Numbers:

Grant number: 392172

First Posted:

Apr 14, 2014

Last Update Posted:

Apr 14, 2014

Last Verified:

Apr 1, 2014

Keywords provided by peyman bidram, Dr peyman bidram, Isfahan University of Medical Sciences

coronary angiography

chronic stable angina

CIN

Additional relevant MeSH terms:

Kidney Diseases

Atorvastatin

Study Results

No Results Posted as of Apr 14, 2014