Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheteri… (NCT02933892) | Clinical Trial Compass
CompletedPhase 4
Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization
United States39 participantsStarted 2016-10
Plain-language 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.
Who can participate
Age range18 Years – 88 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Patients willing to be randomized to TFA or TRA procedure.
✓. Patients signed and dated the informed consent agreeing to participate in the study.
✓. 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.).
✓. Patients ages 18-88 years old.
Exclusion criteria
✕. Patients who have previously undergone a coronary artery bypass graft procedure.
✕. Patients with prior catheterization within the last 5 years.
✕. Women who are pregnant or expect to become pregnant. Pregnancy tests for women of childbearing potential (WOCHP) will be performed as standard of care.
✕. Patients with a history of cardiogenic shock.
✕. Children (under the age of 18).
✕. Medical, geographical, or social factors making study participation impractical, i.e. documented noncompliance, unable to return for follow-ups and lab draws, etc.
What they're measuring
1
Incidence of CIN
Timeframe: 3 days
2
Incidence of CIN
Timeframe: 30 days
3
Need for dialysis
Timeframe: 30 days
Trial details
NCT IDNCT02933892
SponsorTexas Tech University Health Sciences Center