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

Phase 4

Completed

• Conditions: Acute Kidney Injury; Chronic Kidney Disease; Heart Disease
• Interventions: Procedure: Cardiac Catheterization

• Registration Number: NCT02933892
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transradial Access	Cardiac Catheterization	Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the arm access site (transradial access).
Transfemoral Access	Cardiac Catheterization	Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the inner thigh access site (transfemoral access).

Primary Outcome Measures

Name	Time	Method
Incidence of CIN	30 days
Need for dialysis	30 days

Secondary Outcome Measures

Name	Time	Method
All cause mortality	30 days

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States