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

Ischemic Heart Disease Clinical Trial

Official title:

The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468401
• Other study ID #: 0103-15-MMC
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: November 19, 2016
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Myocardial Ischemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glomerular filtration rate following coronary angiography or intervention	Significant changes are defined as a reduction =25% in glomerular filtration rate	24 and 48 hours post procedure	No