Study Summary
This trial will compare the incidence of a kidney complication called contrast-induced nephropathy between two ways of accessing the heart during a catheterization procedure.
Eligible Conditions
- Cardiovascular Disease
- Acute Kidney Injury
- Chronic Kidney Disease
Treatment Effectiveness
Phase-Based Effectiveness
Phase 4
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 30 days
30 days
All cause mortality
Incidence of CIN
Need for dialysis
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2 Treatment Groups
Transradial Access
1 of 2
Transfemoral Access
1 of 2
Active Control
100 Total Participants · 2 Treatment Groups
Primary Treatment: Transradial Access · No Placebo Group · Phase 4
Transradial Access
Procedure
ActiveComparator Group · 1 Intervention: Cardiac Catheterization · Intervention Types: ProcedureTransfemoral Access
Procedure
ActiveComparator Group · 1 Intervention: Cardiac Catheterization · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days
Who is running the clinical trial?
Texas Tech University Health Sciences CenterLead Sponsor
100 Previous Clinical Trials
9,965 Total Patients Enrolled
Subasit Acharji, MDPrincipal InvestigatorTexas Tech University Health Sciences Center
Eligibility Criteria
Age 18 - 88 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Haase, Michael, Rinaldo Bellomo, George Matalanis, Paolo Calzavacca, Duska Dragun, and Anja Haase-Fielitz. 2009. “A Comparison of the RIFLE and Acute Kidney Injury Network Classifications for Cardiac Surgery–associated Acute Kidney Injury: A Prospective Cohort Study”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2009.07.007.
- Sunder, Sham, Rajesh Jayaraman, Himanshu Sekhar Mahapatra, Satyanand Sathi, Venkata Ramanan, Prabhu Kanchi, Anurag Gupta, Sunil Kumar Daksh, and Pranit Ram. 2014. “Estimation of Renal Function in the Intensive Care Unit: The Covert Concepts Brought to Light”. Journal of Intensive Care. Springer Science and Business Media LLC. doi:10.1186/2052-0492-2-31.
- Kim, Jeehyoung, and Wonshik Shin. 2014. “How to Do Random Allocation (randomization)”. Clinics in Orthopedic Surgery. The Korean Orthopaedic Association. doi:10.4055/cios.2014.6.1.103.
- Mehran, Roxana, Eve D. Aymong, Eugenia Nikolsky, Zoran Lasic, Ioannis Iakovou, Martin Fahy, Gary S. Mintz, et al.. 2004. “A Simple Risk Score for Prediction of Contrast-induced Nephropathy After Percutaneous Coronary Intervention”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2004.06.068.
- Caputo, Ronald P., Jennifer A. Tremmel, Sunil Rao, Ian C. Gilchrist, Christopher Pyne, Samir Pancholy, Douglas Frasier, et al.. 2011. “Transradial Arterial Access for Coronary and Peripheral Procedures: Executive Summary by the Transradial Committee of the SCAI”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.23052.
- Vassalotti, Joseph A., Robert Centor, Barbara J. Turner, Raquel C. Greer, Michael Choi, and Thomas D. Sequist. 2016. “Practical Approach to Detection and Management of Chronic Kidney Disease for the Primary Care Clinician”. The American Journal of Medicine. Elsevier BV. doi:10.1016/j.amjmed.2015.08.025.
- Tonelli, Marcello, Natasha Wiebe, Bruce Culleton, Andrew House, Chris Rabbat, Mei Fok, Finlay McAlister, and Amit X. Garg. 2006. “Chronic Kidney Disease and Mortality Risk: A Systematic Review”. Journal of the American Society of Nephrology. American Society of Nephrology (ASN). doi:10.1681/asn.2005101085.
- Vuurmans, T., J. Byrne, E. Fretz, C. Janssen, J. D. Hilton, W. P. Klinke, O. Djurdjev, and A. Levin. 2010. “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. BMJ. doi:10.1136/hrt.2009.192294.
- Jolly, Sanjit S, Salim Yusuf, John Cairns, Kari Niemelä, Denis Xavier, Petr Widimsky, Andrzej Budaj, et al.. 2011. “Radial Versus Femoral Access for Coronary Angiography and Intervention in Patients with Acute Coronary Syndromes (RIVAL): A Randomised, Parallel Group, Multicentre Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(11)60404-2.
- Bertrand, Olivier F., Patrick Bélisle, Dominique Joyal, Olivier Costerousse, Sunil V. Rao, Sanjit S. Jolly, David Meerkin, and Lawrence Joseph. 2012. “Comparison of Transradial and Femoral Approaches for Percutaneous Coronary Interventions: A Systematic Review and Hierarchical Bayesian Meta-analysis”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2012.01.015.
- Kooiman, Judith, Milan Seth, Simon Dixon, David Wohns, Thomas LaLonde, Sunil V. Rao, and Hitinder S. Gurm. 2014. “Risk of Acute Kidney Injury After Percutaneous Coronary Interventions Using Radial Versus Femoral Vascular Access”. Circulation: Cardiovascular Interventions. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circinterventions.113.000778.
- Ohno, Yohei, Yuichiro Maekawa, Hiroaki Miyata, Soushin Inoue, Shiro Ishikawa, Koichiro Sueyoshi, Shigetaka Noma, Akio Kawamura, Shun Kohsaka, and Keiichi Fukuda. 2013. “Impact of Periprocedural Bleeding on Incidence of Contrast-induced Acute Kidney Injury in Patients Treated with Percutaneous Coronary Intervention”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2013.03.086.
- Dangas, George, Ioannis Iakovou, Eugenia Nikolsky, Eve D. Aymong, Gary S. Mintz, Nicholas N. Kipshidze, Alexandra J. Lansky, et al.. 2005. “Contrast-induced Nephropathy After Percutaneous Coronary Interventions in Relation to Chronic Kidney Disease and Hemodynamic Variables”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/j.amjcard.2004.08.056.
- Parfrey, Patrick S., Sheila M. Griffiths, Brendan J. Barrett, Michael D. Paul, Margot Genge, John Withers, Nadir Farid, and Patrick J. McManamon. 1989. “Contrast Material-induced Renal Failure in Patients with Diabetes Mellitus, Renal Insufficiency, or Both”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm198901193200303.
- Parfrey, Patrick S., Sheila M. Griffiths, Brendan J. Barrett, Michael D. Paul, Margot Genge, John Withers, Nadir Farid, and Patrick J. McManamon. 1989. “Contrast Material-induced Renal Failure in Patients with Diabetes Mellitus, Renal Insufficiency, or Both”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm198901193200303.
- Jolly, Sanjit S, Salim Yusuf, John Cairns, Kari Niemelä, Denis Xavier, Petr Widimsky, Andrzej Budaj, et al.. 2011. “Radial Versus Femoral Access for Coronary Angiography and Intervention in Patients with Acute Coronary Syndromes (RIVAL): A Randomised, Parallel Group, Multicentre Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(11)60404-2.
- Caputo, Ronald P., Jennifer A. Tremmel, Sunil Rao, Ian C. Gilchrist, Christopher Pyne, Samir Pancholy, Douglas Frasier, et al.. 2011. “Transradial Arterial Access for Coronary and Peripheral Procedures: Executive Summary by the Transradial Committee of the SCAI”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.23052.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2016. "Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02933892.
Frequently Asked Questions
What is the cap on the number of volunteers involved in this experiment?
"Affirmative. The information on clinicaltrials.gov confirms that this medical trial, initially published on October 1st 2016, is currently recruiting participants. One hundred individuals need to be recruited from a single site." - Anonymous Online Contributor
Unverified Answer
Is there an opportunity for me to participate in this scientific inquiry?
"This research initiative is seeking a cohort of 100 individuals aged 18-88 diagnosed with acute kidney injury who are scheduled to undergo non-emergent cardiac catheterization at University Medical Center Hospital, Lubbock, TX between January 2016 and 2018. Additionally, those meeting the above requirements must be willing to accept randomisation into either TFA or TRA procedures." - Anonymous Online Contributor
Unverified Answer
Are new participants being accepted for this clinical experiment?
"According to clinicaltrials.gov, this experiment is seeking suitable candidates and has been since October 1st 2016. The last edit was made on 10/10/2022." - Anonymous Online Contributor
Unverified Answer
To what degree might Transradial Access be deemed hazardous to patients?
"Transradial Access has attained a score of 3 as it is at the fourth stage in its clinical trial process, which implies that this treatment has already obtained approval." - Anonymous Online Contributor
Unverified Answer
Is eligibility for this trial limited to participants younger than 80 years old?
"This medical study is only recruiting applicants aged 18 to 88. There are 133 separate trials for younger participants and 853 studies that focus on elderly patients over the age of 65." - Anonymous Online Contributor
Unverified Answer