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Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization (RADIAL-CKD)

Primary Purpose

Chronic Kidney Disease, Acute Kidney Injury, Heart Disease

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Cardiac Catheterization

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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.

Sites / Locations

Texas Tech University Health Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Transradial Access

Transfemoral Access

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of CIN

Need for dialysis

Secondary Outcome Measures

All cause mortality

Full Information

NCT ID

NCT02933892

First Posted

October 12, 2016

Last Updated

March 9, 2023

Sponsor

Texas Tech University Health Sciences Center

1. Study Identification

Unique Protocol Identification Number

NCT02933892

Brief Title

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

Acronym

RADIAL-CKD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2016 (undefined)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Acute Kidney Injury, Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transradial Access

Arm Type

Active Comparator

Arm Description

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

Arm Title

Transfemoral Access

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Cardiac Catheterization

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of CIN

Time Frame

3 days

Title

Incidence of CIN

Time Frame

30 days

Title

Need for dialysis

Time Frame

30 days

Secondary Outcome Measure Information:

Title

All cause mortality

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ami Knox

ami.knox@ttuhsc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Subasit Acharji, MD

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Tech University Health Sciences Center

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79430

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siva Iyer

siva.iyer@ttuhsc.edu

First Name & Middle Initial & Last Name & Degree

Subasit Acharji, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Yes, the research group may be potentially interested in sending data for further analyses.

Citations:

PubMed Identifier

21544927

Citation

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.

Results Reference

background

PubMed Identifier

22520530

Citation

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.

Results Reference

background

PubMed Identifier

26391748

Citation

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.

Results Reference

background

PubMed Identifier

16738019

Citation

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.

Results Reference

background

PubMed Identifier

2643041

Citation

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.

Results Reference

background

PubMed Identifier

19733864

Citation

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.

Results Reference

background

PubMed Identifier

15619387

Citation

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.

Results Reference

background

PubMed Identifier

23770181

Citation

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.

Results Reference

background

PubMed Identifier

20668106

Citation

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.

Results Reference

background

PubMed Identifier

24569598

Citation

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.

Results Reference

background

PubMed Identifier

25520843

Citation

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.

Results Reference

background

PubMed Identifier

24605197

Citation

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.

Results Reference

background

PubMed Identifier

15464318

Citation

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.

Results Reference

background

PubMed Identifier

21470671

Citation

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. Erratum In: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30.

Results Reference

background

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

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