Clinical Trial: Nephrogenic Systemic Fibrosis With Gadollinum

Study Status: Suspended
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Prevalence and Severity of Nephrogenic Systemic Fibrosis in Patients Whom Underwent Imaging With Gadollinium(MRI/MRA) in University Hospital of Tehran Heart Center in

Brief Summary:

Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with severe renal failure mainly in patients under dialysis in whom gadollinum is being used.

The investigators will evaluate the prevalence and severity of NSF in patients with different degree of renal failure whom underwent imaging with Gadolinum.

Detailed Summary:

NSF is a progressive and potentially fatal disease reported mainly in End Stage Renal Disease (ESRD) patients in whom Gadolinume been used as contrast agent. Skin is the main organ of involvement but other vital organs like myocard,lung,liver may also be involved.Gadollinum is known as a safe contrast in renal disease patients in comparison with conventional nephrotoxic radiocontrast agents,but with increasing reports of NSF with Gadollinum the use of this agent in renal failure patients is under question.

We will retrospectively evaluate the occurrence of this complication in all patients with different degree of renal failure whom underwent MRA or MRI with Gadollinum in Tehran Heart Center since 2003 till now and we will describe the severity and distribution pattern of lesions and the relation of this complication to the severity of renal failure.

Sponsor: Imam Khomeini Hospital

Current Primary Outcome: occurrence of fibrosis [ Time Frame: after 2 month of exposure with gadollinum ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Imam Khomeini Hospital

Dates:
Date Received: October 26, 2009
Date Started: July 2008
Date Completion: August 2012
Last Updated: June 21, 2012
Last Verified: June 2012