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Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468401
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Pereg David, Meir Medical Center

Brief Summary:
There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions

Condition or disease Intervention/treatment Phase
Kidney Disease, Chronic Ischemic Heart Disease Procedure: Percutaneous coronary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
Study Start Date : September 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Coronary angiography
Patients undergoing coronary angio with or without percutaneous coronary intervention using a new protocol designed to minimize the exposure to contrast medium
Procedure: Percutaneous coronary intervention
Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye




Primary Outcome Measures :
  1. Changes in glomerular filtration rate following coronary angiography or intervention [ Time Frame: 24 and 48 hours post procedure ]
    Significant changes are defined as a reduction ≥25% in glomerular filtration rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with estimated glomerular filtration rate<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:

  1. Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
  2. Non ST-elevation acute coronary syndrome with a GRACE score>110

Exclusion Criteria:

  • Patients on dialysis or those planned for dialysis in the next 3 months.
  • Patients with ST-elevation myocardial infarction
  • No symptoms or signs of heart failure
  • Treatment with IV diuretics during the 48 hours prior to enrolment
  • Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
  • Patients post coronary artery bypass surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468401


Locations
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Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pereg David, Dr, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02468401    
Other Study ID Numbers: 0103-15-MMC
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Urologic Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases