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Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization, A Single Center Randomized Controlled Trial


Description

The investigators will conduct a randomized controlled trial that aims to compare the incidence of contrast-induced nephropathy between transradial- and transfemoral-access cardiac catheterization.Cardiac catheterization is a medical procedure used to diagnose and treat heart conditions. Approaching the heart can be done by different access sites: via the femoral artery (transfemoral) or the radial artery (transradial). Transfemoral access (TFA) is the primary mode of arterial access. Several clinical trials have demonstrated the benefit of transradial over transfemoral approach. The primary advantage of transradial approach is a significant reduction of access-site complications. Chronic Kidney Disease (CKD) is a serious condition associated with premature mortality, decreased quality of life, and increased health-care expenditures. ). It is commonly found in patients with diabetes, hypertension, hyperlipidemia, coronary artery disease, or combinations of these risk factors. Coronary

Trial Eligibility

Inclusion Criteria: 1. Patients scheduled to undergo non-emergent cardiac catheterization at University Medical Center Hospital, Lubbock, TX from January 2016 to January 2018. Emergent cardiac catheterizations will be defined as a catheterization scheduled \< 24 hours from a cardiac event. 2. Patients willing to be randomized to TFA or TRA procedure. 3. Patients signed and dated the informed consent agreeing to participate in the study. 4. Patients with chronic kidney disease, defined as eGFR = 15-59mL/min defined by the MDRD formula. (eGFR is a standard of care measurement for all patients undergoing coronary intervention.). 5. Patients ages 18-88 years old. Exclusion Criteria: 1. Patients who have previously undergone a coronary artery bypass graft procedure. 2. Patients with prior catheterization within the last 5 years. 3. Women who are pregnant or expect to become pregnant. Pregnancy tests for women of childbearing potential (WOCHP) will be performed as standard of care. 4. Patients with a history of cardiogenic shock. 5. Children (under the age of 18). 6. Medical, geographical, or social factors making study participation impractical, i.e. documented noncompliance, unable to return for follow-ups and lab draws, etc. 7. A positive Allen's Test on the right radial artery. 8. Any condition preventing TRA or TFA access. 9. Contrast used within the previous 3 weeks. 10. Allergy to contrast dye. 11. Inability to successfully access the artery randomized to use.

Study Info

Organization

Texas Tech University Health Sciences Center


Primary Outcome

Incidence of CIN


Outcome Timeframe 3 days

NCTID NCT02933892

Phases PHASE4

Primary Purpose TREATMENT

Start Date 2016-10

Completion Date 2024-08

Enrollment Target 100

Interventions

PROCEDURE Cardiac Catheterization

Locations Recruiting

Texas Tech University Health Sciences Center

United States, Texas, Lubbock


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