Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization



Status:Recruiting
Conditions:Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 88
Updated:12/7/2018
Start Date:October 2016
End Date:December 2019
Contact:Ami Knox
Email:ami.knox@ttuhsc.edu

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

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
artery disease and CKD are often comorbid conditions seen in the cath lab. Cardiac
catheterization is a mainstay of diagnosis and treatment for coronary artery disease and 58%
of deaths in CKD are related to cardiovascular deaths. Patients with CKD and who undergo a
cardiac catheterization are at risk for contrast-induced nephropathy (CIN) due to the dye
used during the procedure.

The investigators will conduct a randomized controlled trial that aims to compare the
incidence of CIN between transradial and transfemoral cardiac catheterization.

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.
We found this trial at
1
site
Lubbock, Texas 79430
Principal Investigator: Subasit Acharji, MD
?
mi
from
Lubbock, TX
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