Left vs. Right Radial Approach for Routine Catheterization of Heart Transplant Patients

NCT02163031 | Completed DMC

• 1 other identifier: 0187635
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Orthotopic heart transplantation is a well established therapeutic measure for end stage heart failure, leading to significant improvements in survival and quality of life. In the routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac catheterization for early detection of allograft vascular disease. The coronary angiography of these patients is characterized for several technical difficulties, generally related to the presence of the aortotomy with anomalous implantation of the coronary ostia and to the orthotopic position of the allograft. For these reasons, trans femoral approach is usually preferred. In the last two decades, trans radial approach for coronary angiography emerged to be effective, safe and able to improve patient comfort. However, there is no universal consensus on the optimal choice of radial access from either the left or the right artery. Currently, this choice is largely dependent on the operator's preference. The trans right radial approach is generally preferred in routine clinical practice mainly due to its easier catheter manipulation for the operators from patient's right side, and the current design of radial compression devices for the right wrist in medical market. As such, a major barrier to prevent the wide adoption of the left radial access lies in some difficulty to reach the left wrist leaning over the patient, particularly for shorter operators or in obese patients. However, a great deal of attention has been recently directed toward the trans left radial access, as it has an important anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the left coronary ostium, which could also reduce the risk of cerebrovascular complications. However, no data are available about the performance of trans left radial or trans-right radial approach in coronary angiography orthotopic heart transplantation patients. However, in this particular setting of patients, the left radial approach might reduce the technical difficulties related to the anatomical variations. In this single centre, prospective, randomized study, we sought to compare trans right radial versus trans left radial approach in terms of amount of contrast medium, radiation exposure, number of catheters used, cross over to the other access site rate and local and systemic complications in orthotopic heart transplantation patients.

Conditions

Cardiovascular Disease

Keywords

heart transplant; radial approach; catheterization

Outcome Measures

Primary Outcomes (1)

• Superiority of trans-left radial approach vs. trans right radial approach in terms of amount of contrast medium.

  1 week

Secondary Outcomes (5)

• Superiority of trans-left radial approach in terms of procedural time

  1 week

• Superiority of trans-left radial approach vs. trans-right radial approach in terms of radiation exposure (dose area product, fluoroscopy time, total dose administered from the angiography system)

  1 week

• Superiority of trans-left radial approach vs. trans-right radial approach in terms of number of catheters used

  1 week

• Superiority of trans-left radial approach vs. trans-right radial approach in terms of 4) cross-over to the other access site rate

  1 week

• Superiority of trans-left radial approach vs. trans-right radial approach in terms of 5) local and systemic complications

  1week

Study Arms (2)

right radial approach

ACTIVE COMPARATOR

devices used in the coronary angiography by right radial approach

Device: devices used in the coronary angiography

left radial approach

ACTIVE COMPARATOR

devices used in the coronary angiography by left radial approach

Device: devices used in the coronary angiography

Interventions

devices used in the coronary angiography DEVICE

devices used in coronary angiography by left or right radial route

Also known as: catheters, wires, contrast medium

left radial approach; right radial approach

Eligibility Criteria

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

You may not qualify if:

• in case of an abnormal or doubtful bilateral Allen's test, a pletysmography will be done. The presence of a type A or B curve will be considered a marker of adequate hand collaterals and the procedure will be able by this access. Only the presence of bilateral type C or D curves will be considered a contraindication to trans radial approach.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (3)

• Norgaz T, Gorgulu S, Dagdelen S. A randomized study comparing the effectiveness of right and left radial approach for coronary angiography. Catheter Cardiovasc Interv. 2012 Aug 1;80(2):260-4. doi: 10.1002/ccd.23463. Epub 2012 Feb 14.

  PMID: 22334420 RESULT

• Biondi-Zoccai G, Sciahbasi A, Bodi V, Fernandez-Portales J, Kanei Y, Romagnoli E, Agostoni P, Sangiorgi G, Lotrionte M, Modena MG. Right versus left radial artery access for coronary procedures: an international collaborative systematic review and meta-analysis including 5 randomized trials and 3210 patients. Int J Cardiol. 2013 Jul 1;166(3):621-6. doi: 10.1016/j.ijcard.2011.11.100. Epub 2011 Dec 20.

  PMID: 22192284 RESULT

• Sciahbasi A, Romagnoli E, Burzotta F, Trani C, Sarandrea A, Summaria F, Pendenza G, Tommasino A, Patrizi R, Mazzari M, Mongiardo R, Lioy E. Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study. Am Heart J. 2011 Jan;161(1):172-9. doi: 10.1016/j.ahj.2010.10.003.

  PMID: 21167351 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Catheters; Bone Wires

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Internal Fixators; Prostheses and Implants; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Manel Sabatè

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 13, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)