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

NCT02468401 | Completed

• 1 other identifier: 0103-15-MMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Disease, Chronic; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Coronary angiography

EXPERIMENTAL

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

Interventions

Percutaneous coronary intervention PROCEDURE

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

Coronary angiography

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with estimated glomerular filtration rate\<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:
• Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
• Non ST-elevation acute coronary syndrome with a GRACE score\>110

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel, Israel

Location

Related Publications (1)

• Rozenbaum Z, Benchetrit S, Rozenbaum E, Neumark E, Mosseri M, Pereg D. Ultra-Low Contrast Volume for Patients with Advanced Chronic Kidney Disease Undergoing Coronary Procedures. Nephron. 2018;138(4):296-302. doi: 10.1159/000485648. Epub 2018 Jan 24.

  PMID: 29393219 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 10, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

IL (1)