Nephrogenic Systemic Fibrosis With Gadollinum (NSF)
| Tracking Information | |||||
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| First Received Date ICMJE | October 26, 2009 | ||||
| Last Updated Date | June 21, 2012 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
occurrence of fibrosis [ Time Frame: after 2 month of exposure with gadollinum ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01359345 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nephrogenic Systemic Fibrosis With Gadollinum | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: gadollinum
use of on injection gadollinum Iv for imaging |
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| Study Arm (s) | Experimental: A
The patients with renal failure in whom Gadollinume has being used
Intervention: Drug: gadollinum |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | August 2012 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01359345 | ||||
| Other Study ID Numbers ICMJE | GADOLLINUM, 6553-30-04-86 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mohammad Reza Khatami, Imam Khomeini Hospital | ||||
| Study Sponsor ICMJE | Imam Khomeini Hospital | ||||
| Collaborators ICMJE | Tehran Heart Center | ||||
| Investigators ICMJE |
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| Information Provided By | Imam Khomeini Hospital | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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