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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Manel Sabate, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT02163031
First received: June 9, 2014
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Device: devices used in the coronary angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: RADIAL 2 Heart Transplant Study: Left vs. Right Radial Approach Randomized Comparison for Routine Catheterization of Heart Transplant Patients

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Superiority of trans-left radial approach vs. trans right radial approach in terms of amount of contrast medium. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Superiority of trans-left radial approach in terms of procedural time [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Superiority of trans-left radial approach vs. trans-right radial approach in terms of number of catheters used [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Superiority of trans-left radial approach vs. trans-right radial approach in terms of 4) cross-over to the other access site rate [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Superiority of trans-left radial approach vs. trans-right radial approach in terms of 5) local and systemic complications [ Time Frame: 1week ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: right radial approach
devices used in the coronary angiography by right radial approach
Device: devices used in the coronary angiography
devices used in coronary angiography by left or right radial route
Other Names:
  • catheters
  • wires
  • contrast medium
Active Comparator: left radial approach
devices used in the coronary angiography by left radial approach
Device: devices used in the coronary angiography
devices used in coronary angiography by left or right radial route
Other Names:
  • catheters
  • wires
  • contrast medium

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: eligible transplanted patients scheduled for a routine coronary angiography with age >18 years old.

Exclusion Criteria:

  1. chronic renal insufficiency (creatinine >2.0 mg/dl) with the potential necessity of using the radial artery as a native fistula will be considered one of the exclusion criteria;
  2. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02163031

Contacts
Contact: Manel Sabate, MD, Phd +34932279305 masabate@clinic.ub.es

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Manel Sabaté, MD, Phd    +34932279305    masabate@clinic.ub.es   
Sub-Investigator: Victoria Martin Yuste, Md, Phd         
Sub-Investigator: Giancarla Scalone, MD         
Sub-Investigator: Salvatore Brugaletta, MD, Phd         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Manel Sabatè Hospital Clinic of Barcelona
  More Information

Publications:
Responsible Party: Manel Sabate, MD, Phd, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02163031     History of Changes
Other Study ID Numbers: 0187635
Study First Received: June 9, 2014
Last Updated: June 12, 2014
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya

Keywords provided by Hospital Clinic of Barcelona:
heart transplant
radial approach
catheterization

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014