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

NCT02933892 | Completed Phase 4 DMC

• 1 other identifier: L16-092
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Acute Kidney Injury; Heart Disease

Outcome Measures

Primary Outcomes (3)

• Incidence of CIN

  3 days

• Incidence of CIN

  30 days

• Need for dialysis

  30 days

Secondary Outcomes (1)

• All cause mortality

  30 days

Study Arms (2)

Transradial Access

ACTIVE COMPARATOR

Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the arm access site (transradial access).

Procedure: Cardiac Catheterization

Transfemoral Access

ACTIVE COMPARATOR

Patients scheduled for cardiac catheterization will be randomly assigned to have the doctor insert the catheter via the inner thigh access site (transfemoral access).

Procedure: Cardiac Catheterization

Interventions

Cardiac Catheterization PROCEDURE

Cardiac catheterization is a diagnostic procedure used to treat and diagnose heart conditions.

Transfemoral Access; Transradial Access

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• A positive Allen's Test on the right radial artery.
• Any condition preventing TRA or TFA access.
• Contrast used within the previous 3 weeks.
• Allergy to contrast dye.
• Inability to successfully access the artery randomized to use.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (14)

• 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.

  PMID: 21544927 BACKGROUND

• 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.

  PMID: 22520530 BACKGROUND

• 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.

  PMID: 26391748 BACKGROUND

• 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.

  PMID: 16738019 BACKGROUND

• 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.

  PMID: 2643041 BACKGROUND

• 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.

  PMID: 19733864 BACKGROUND

• 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.

  PMID: 15619387 BACKGROUND

• 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.

  PMID: 23770181 BACKGROUND

• 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.

  PMID: 20668106 BACKGROUND

• 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.

  PMID: 24569598 BACKGROUND

• 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.

  PMID: 25520843 BACKGROUND

• 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.

  PMID: 24605197 BACKGROUND

• 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.

  PMID: 15464318 BACKGROUND

• 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.

  PMID: 21470671 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury; Heart Diseases

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Subasit Acharji, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)