Nephrogenic Systemic Fibrosis With Gadollinum (NSF)
|ClinicalTrials.gov Identifier: NCT01359345|
Recruitment Status : Unknown
Verified June 2012 by Mohammad Reza Khatami, Imam Khomeini Hospital.
Recruitment status was: Enrolling by invitation
First Posted : May 24, 2011
Last Update Posted : June 22, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Nephrogenic Systemic Fibrosis Renal Failure||Drug: gadollinum||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2003-2008|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||August 2012|
The patients with renal failure in whom Gadollinume has being used
use of on injection gadollinum Iv for imaging
- occurrence of fibrosis [ Time Frame: after 2 month of exposure with gadollinum ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359345
|Iran, Islamic Republic of|
|Tehran Heart Center|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Mohammad R Khatami, MD||TUMS|