Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy

Coronary Artery Disease Clinical Trial

— L-RECORD  

Official title:

Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393052
• Other study ID #: 5602
• Status: Completed
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: June 2018
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.

Description:

Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age over 18 years

2. Written informed consent

3. Clinical indication for coronary angiography in a patient with prior history of CABG

4. Left radial artery has not been used as a graft during CABG

Exclusion Criteria:

1. Age over 90 years

2. Patient's refusal to participate in the study

3. Hemodynamic instability of the patient

4. Failure to place a sheath at the randomization access site

5. Arteriovenous fistula at the left upper limb

6. Use of right internal mammary artery as a graft during CABG

7. Creatinine clearance <30 ml/min

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Vascular Access Complication

Intervention

Procedure:
• Coronary Angiography
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patras	Achaia

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of Patras	AHEPA University Hospital, Korgialenio-Benakio Red Cross Hospital, University General Hospital of Heraklion

Country where clinical trial is conducted

Greece, 

References & Publications (8)

Baker NC, O'Connell EW, Htun WW, Sun H, Green SM, Skelding KA, Blankenship JC, Scott TD, Berger PB. Safety of coronary angiography and percutaneous coronary intervention via the radial versus femoral route in patients on uninterrupted oral anticoagulation with warfarin. Am Heart J. 2014 Oct;168(4):537-44. doi: 10.1016/j.ahj.2014.06.016. Epub 2014 Jul 3. — View Citation

Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1. Review. — View Citation

Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj A, Niemelä 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. Erratum in: Lancet. 2011 Jul 2;378(9785):30. — View Citation

Koltowski L, Koltowska-Haggstrom M, Filipiak KJ, Kochman J, Golicki D, Pietrasik A, Huczek Z, Balsam P, Scibisz A, Opolski G. Quality of life in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention--radial versus femoral access (from the OCEAN RACE Trial). Am J Cardiol. 2014 Aug 15;114(4):516-21. doi: 10.1016/j.amjcard.2014.05.030. Epub 2014 Jun 6. — View Citation

Koutouzis M, Matejka G, Olivecrona G, Grip L, Albertsson P. Radial vs. femoral approach for primary percutaneous coronary intervention in octogenarians. Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):79-83. doi: 10.1016/j.carrev.2009.04.107. — View Citation

Louvard Y, Lefèvre T, Allain A, Morice M. Coronary angiography through the radial or the femoral approach: The CARAFE study. Catheter Cardiovasc Interv. 2001 Feb;52(2):181-7. — View Citation

Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16. — View Citation

Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net Procedure Time	The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography	24 hours
Secondary	Total Procedure Time	The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography	24 hours
Secondary	Fluoroscopy Time	Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography	24 hours
Secondary	Dose Area Product	Radiation DAP (mGy*cm2) during the diagnostic coronary angiography	24 hours
Secondary	Contrast Volume	Contrast volume (ml) used during the diagnostic coronary angiography	24 hours
Secondary	Crossover access site	Need for crossover access site, other than this of randomization	24 hours
Secondary	Major Cardiovascular Events	Death, stroke, acute myocardial infarction	24 hours
Secondary	Vascular Complications	Vascular access complications	24 hours