Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization
NCT ID: NCT02933892
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
39 participants
INTERVENTIONAL
2016-10-31
2024-08-30
Brief Summary
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Detailed Description
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The investigators will conduct a randomized controlled trial that aims to compare the incidence of CIN between transradial and transfemoral cardiac catheterization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transradial Access
Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the arm access site (transradial access).
Cardiac Catheterization
Cardiac catheterization is a diagnostic procedure used to treat and diagnose heart conditions.
Transfemoral Access
Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the inner thigh access site (transfemoral access).
Cardiac Catheterization
Cardiac catheterization is a diagnostic procedure used to treat and diagnose heart conditions.
Interventions
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Cardiac Catheterization
Cardiac catheterization is a diagnostic procedure used to treat and diagnose heart conditions.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
88 Years
ALL
No
Sponsors
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Texas Tech University Health Sciences Center
OTHER
Responsible Party
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Principal Investigators
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Subasit Acharji, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University Health Sciences Center
Locations
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Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Countries
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References
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Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, Frasier D, Gulati R, Skelding K, Bertrand O, Patel T. Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):823-39. doi: 10.1002/ccd.23052. Epub 2011 May 4.
Bertrand OF, Belisle P, Joyal D, Costerousse O, Rao SV, Jolly SS, Meerkin D, Joseph L. Comparison of transradial and femoral approaches for percutaneous coronary interventions: a systematic review and hierarchical Bayesian meta-analysis. Am Heart J. 2012 Apr;163(4):632-48. doi: 10.1016/j.ahj.2012.01.015.
Vassalotti JA, Centor R, Turner BJ, Greer RC, Choi M, Sequist TD; National Kidney Foundation Kidney Disease Outcomes Quality Initiative. Practical Approach to Detection and Management of Chronic Kidney Disease for the Primary Care Clinician. Am J Med. 2016 Feb;129(2):153-162.e7. doi: 10.1016/j.amjmed.2015.08.025. Epub 2015 Sep 25.
Tonelli M, Wiebe N, Culleton B, House A, Rabbat C, Fok M, McAlister F, Garg AX. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006 Jul;17(7):2034-47. doi: 10.1681/ASN.2005101085. Epub 2006 May 31.
Parfrey PS, Griffiths SM, Barrett BJ, Paul MD, Genge M, Withers J, Farid N, McManamon PJ. Contrast material-induced renal failure in patients with diabetes mellitus, renal insufficiency, or both. A prospective controlled study. N Engl J Med. 1989 Jan 19;320(3):143-9. doi: 10.1056/NEJM198901193200303.
Haase M, Bellomo R, Matalanis G, Calzavacca P, Dragun D, Haase-Fielitz A. A comparison of the RIFLE and Acute Kidney Injury Network classifications for cardiac surgery-associated acute kidney injury: a prospective cohort study. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1370-6. doi: 10.1016/j.jtcvs.2009.07.007. Epub 2009 Sep 5.
Dangas G, Iakovou I, Nikolsky E, Aymong ED, Mintz GS, Kipshidze NN, Lansky AJ, Moussa I, Stone GW, Moses JW, Leon MB, Mehran R. Contrast-induced nephropathy after percutaneous coronary interventions in relation to chronic kidney disease and hemodynamic variables. Am J Cardiol. 2005 Jan 1;95(1):13-9. doi: 10.1016/j.amjcard.2004.08.056.
Ohno Y, Maekawa Y, Miyata H, Inoue S, Ishikawa S, Sueyoshi K, Noma S, Kawamura A, Kohsaka S, Fukuda K. Impact of periprocedural bleeding on incidence of contrast-induced acute kidney injury in patients treated with percutaneous coronary intervention. J Am Coll Cardiol. 2013 Oct 1;62(14):1260-1266. doi: 10.1016/j.jacc.2013.03.086. Epub 2013 Jun 12.
Vuurmans T, Byrne J, Fretz E, Janssen C, Hilton JD, Klinke WP, Djurdjev O, Levin A. Chronic kidney injury in patients after cardiac catheterisation or percutaneous coronary intervention: a comparison of radial and femoral approaches (from the British Columbia Cardiac and Renal Registries). Heart. 2010 Oct;96(19):1538-42. doi: 10.1136/hrt.2009.192294. Epub 2010 Jul 28.
Kooiman J, Seth M, Dixon S, Wohns D, LaLonde T, Rao SV, Gurm HS. Risk of acute kidney injury after percutaneous coronary interventions using radial versus femoral vascular access: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Circ Cardiovasc Interv. 2014 Apr;7(2):190-8. doi: 10.1161/CIRCINTERVENTIONS.113.000778. Epub 2014 Feb 25.
Sunder S, Jayaraman R, Mahapatra HS, Sathi S, Ramanan V, Kanchi P, Gupta A, Daksh SK, Ram P. Estimation of renal function in the intensive care unit: the covert concepts brought to light. J Intensive Care. 2014 May 7;2(1):31. doi: 10.1186/2052-0492-2-31. eCollection 2014.
Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.
Other Identifiers
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L16-092
Identifier Type: -
Identifier Source: org_study_id
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