Neurological Complications Comparing Endoscopically vs. Open Harvest of the Radial Artery (NEO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Christian Lildal Carranza, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01848886
First received: February 25, 2013
Last updated: June 24, 2013
Last verified: May 2013
  Purpose

Coronary artery bypass grafting (CABG) using the radial artery (RA) has since the nineties gone through a revival. The initially reported worse outcome in RA graft patients compared to patients grafted with the saphenous vein (SV) has since been corrected. Studies have shown better patency when using RA, so the RA is going to be preferred more and more especially in younger patients where long time patency is critical. During the last 10 years endoscopic techniques to harvest the RA have evolved. Multiple different techniques have been used, but now the equipment and technique have been refined and are highly reliable. The investigators hypothesize that the endoscopic technique has less complications and a just as good patency as open harvest. There are also two possible ways to use the RA as a graft. One way is sewing it onto the aorta and another way is sewing it onto the mammarian artery. The investigators hypothesize that using it on the mammarian artery is superior as a revascularisation technique with just as good a patency as sewing it directly onto the aorta.


Condition Intervention
Complications Due to Coronary Artery Bypass Graft
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Procedure: Endoscopic radial artery harvest
Procedure: Open radial artery harvest
Procedure: Mammarioradial graft (Y-graft)
Procedure: Aortoradial graft (Free RA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Versus Open Radial Artery Harvest and Mammario-radial Versus Aorto-radial Grafting in Patients Undergoing Coronary Artery Bypass Surgery (The 2x2 Factorial Designed Randomised NEO Trial)

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Sum score of hand function questionnaire [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    Using Likert-type scale scoring system quality of life is assessed after radial artery harvest. The mean values in the ERAH group will be compared to the mean value in the ORAH group at three months after surgery.

  • Occurence of cardiac and cerebrovascular events in aortoradial versus mammarioradial grafting [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
    Occurrence of one of the following cardiac or cerebrovascular events: all cause mortality, myocardial infarction (MI), target vessel revascularisation (TVR) or stroke at one year postoperatively will be compared.


Secondary Outcome Measures:
  • Complications in the donor arm in ERAH versus ORAH [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    Occurrence of complications at three months after surgery. Complications are defined as a composite of haematoma formation, wound dehiscence, or infection will be compared.

  • Clinical neurological examination in donor arm ERAH versus ORAH [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    Clinical examination of subjective cutaneous sensibility will be compared between ERAH versus ORAH groups.

  • Neurological deficits in ERAH versus ORAH [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

    Occurence of deficits in following neurological exams will be compared between ERAH and ORAH

    1. Cutaneous sensibility on both forearms and hands by appraisal of dermatomes. All sensibility modalities are examined:

      1. Cutaneous touch sensibility examined by Von Fray hair
      2. Deep pain sensibility examined by algometry.
    2. Sensory nervous conduction velocity examined on both forearms and hands:

      1. N. medianus (dig. II - hdl); orthodromic technique
      2. N. ulnaris (dig. V - hdl); orthodromic technique
      3. N. radialis (antebrachium - tabatiere); antidromic technique
      4. N. cutaneous antebrachium lateralis (elbow - antebrachium); antidromic technique
      5. N. cutaneous antebrachium medialis (elbow - antebrachium); antidromic technique
    3. Motoric nervous conduction velocity examined on both forearms and hands:

      1. N. medianus (hdl - m. abductor policis brevis (APB), elbow - APB)
      2. N. ulnaris (hdl - m. abductor digiti minimi)


Other Outcome Measures:
  • Vascular function in the donor arm of the ERAH and ORAH groups compared to non-donor arms. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    MIBI scan after exercise induced relative ischemia will be compared between donor versus non-donor arms.

  • Graft patency in ERAH versus ORAH [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
    MSCT will be used to evaluate patency.

  • Graft patency in aortoradial versus mammarioradial grafting [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
    MSCT will be used to evaluate patency.

  • Change in handgrip strength [ Time Frame: the day before surgery and 1 year postoperatively. ] [ Designated as safety issue: No ]
    Change in handgrip strength will be measured in the conduit donor arm and compared between ERAH versus ORAH.

  • Change in muscular function in ERAH versus ORAH [ Time Frame: the day before surgery and 1 year postoperatively ] [ Designated as safety issue: No ]

    Following muscles are rated according to the Oxford Scale for grading muscle strength (see table 7) the day before surgery and at one year postoperatively:

    • m. abductor pollicis brevis
    • m. abductor digiti minimi
    • mm. interosseus palmares
    • m. flexor digitorum profundus II+V
    • m. extensor digitorum The change in muscular function will be compared between ERAH versus ORAH.

  • Serious adverse events in ERAH versus ORAH [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
    Occurrence of the following serious adverse events at time point one year after surgery: reoperation for bleeding; revascularisation; myocardial infarction; stroke; or death will be compared between ERAH and ORAH.

  • Scar evaluation in ERAH versus ORAH [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
    Using Stony Brooke Scar Evaluation Score the scars will be evaluated and the mean scores compared between ERAH versus ORAH groups.

  • Neuropathic pain symptoms and signs in ERAH versus ORAH [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    The Leeds assessment of neuropathic symptoms and signs (LANNS) pain scale will be used after 3 months to compare pain in ERAH versus ORAH groups.


Estimated Enrollment: 280
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Grp 1: ERAH, Mammarioradial (Y-graft)
Endoscopic radial artery harvest Mammarioradial graft (Y-graft) In this group the radial artery is harvested as an endoscopic procedure and positioned on the heart as an composite graft (Y-graft).
Procedure: Endoscopic radial artery harvest
Radial artery harvest is performed as an endoscopic procedure.
Procedure: Mammarioradial graft (Y-graft)
The radial artery is used as an composite graft positioned on the internal mammarian artery.
Grp 2: ERAH, Aortoradial (Free RA)
Endoscopic radial artery harvest Aortooradial (free RA) In this group the radial artery is harvested as an endoscopic procedure and positioned on the heart as an free RA graft.
Procedure: Endoscopic radial artery harvest
Radial artery harvest is performed as an endoscopic procedure.
Procedure: Aortoradial graft (Free RA)
The radial artery is used as an free graft positioned on the aorta.
Grp 3: ORAH, Mammarioradial (Y-graft)
Open radial artery harvest Mammarioradial graft (Y-graft) In this group the radial artery is harvested as an open procedure and positioned on the heart as an composite graft (Y-graft).
Procedure: Open radial artery harvest
Radial artery harvest is performed as an open procedure.
Procedure: Mammarioradial graft (Y-graft)
The radial artery is used as an composite graft positioned on the internal mammarian artery.
Grp 4: ORAH, Aortoradial graft (Free RA)
Aortooradial graft (free RA) Open radial artery harvest In this group the radial artery is harvested as an open procedure and positioned on the heart as an free RA graft.
Procedure: Open radial artery harvest
Radial artery harvest is performed as an open procedure.
Procedure: Aortoradial graft (Free RA)
The radial artery is used as an free graft positioned on the aorta.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria

  • Elective/sub acute CABG as an isolated procedure.
  • Age > 18 years
  • Multi-vessel disease
  • Non-dominant arm is eligible for radial artery harvest
  • Written informed consent

Exclusion Criteria

  • Geographically not available for follow up
  • Modified Allen's test indicating insufficient ulnary artery perfusion
  • Valve surgery, ablation surgery or any kind of concomitant surgery during same admission.
  • Acute operation (<24 hours from admission)
  • Dialysis
  • Preoperative neurological deficit on the donor arm
  • LVEF < 20% preoperative
  • Former sternotomy
  • Contrast allergy
  • Malignant disease
  • No written informed consent
  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: NCT01848886

Contacts
Contact: Christian L Carranza, MD +4535451488 neo-trial@thoraxkir.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Christian L Carranza, MD    +4535451488    neo-trial@thoraxkir.dk   
Principal Investigator: Christian L Carranza, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Christian L Carranza, MD Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark
Study Chair: Daniel Steinbrüchel, Prof MD DMSc Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark
Study Chair: Peter Skov Olsen, MD DMSc Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen, Denmark
Study Chair: Christian Gluud, MD DMSc Copenhagen Trial Unit, Rigshospitalet, Copenhagen, Denmark
Study Chair: Martin Ballegaard, MD PhD Department of Clinical Neurophysiology, Rigshospitalet, Copenhagen, Denmark
Study Chair: Hans Høgenhaven, Prof MD DMSc Department of Clinical Neurophysiology, Rigshospitalet, Copenhagen, Denmark
Study Chair: Philip Hasbak, MD PhD Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark
Study Chair: Andreas Kjær, Prof MD DMSc Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen, Denmark
Study Chair: Klaus F Kofoed, MD DMSc Department of Cardiology and Radiology, Rigshospitalet, Copenhagen, Denmark
Study Chair: Mads Werner, MD, DMSc Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Lildal Carranza, MD, Specialist in Cardio-Thoracic Surgery, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01848886     History of Changes
Other Study ID Numbers: H-3-2012-116, H-3-2012-116
Study First Received: February 25, 2013
Last Updated: June 24, 2013
Health Authority: Denmark: National Board of Health
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
ERAH
Endoscopic Radial Artery Harvest
Y-graft
Radial Artery Harvest
Total Arterial Revascularisation
CABG
Radial Artery Conduit

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014