Condition category
Nervous System Diseases
Date applied
19/09/2004
Date assigned
22/10/2004
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Marjan Jahangiri

ORCID ID

Contact details

Department of Cardiac Surgery
Atkinson Morley Wing
St George's Hospital & Medical School
London
SW17 0QT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised study of neurocognitive outcome and cerebral embolic events in patients undergoing off-pump and on-pump coronary artery bypass graft surgery

Acronym

Study hypothesis

1. Cerebral injury, determined by neuropsychological testing, is reduced in off-pump compared with on-pump patients
2. Perioperative embolisation is reduced in off-pump, compared with on-pump, surgery
3. Any reduction in cerebral injury is mediated by a reduction in perioperative embolisation

Ethics approval

Wandsworth Local Research Ethics Committee (ref: 01.78.6, R+D Number 00.2431), in October 2001.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neurocognitive dysfunction

Intervention

Patients are divided into two groups: those undergoing on-pump and those having off-pump coronary artery surgery. Comparisons between intraoperative cerebral embolic burden and postoperative neurocognitive function are made between the two groups.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Post-operative composite neurocognitive score at six months and three years.

Secondary outcome measures

The neurocognitive score at discharge and at six weeks, and the total intra-operative microemboli count.

Overall trial start date

01/08/2002

Overall trial end date

01/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing first time elective coronary artery bypass surgery.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Previous cerebrovascular accident or Transient Ischaemic Attack (TIA)
2. Right or left internal carotid artery stenosis more than or equal to 50%
3. Previous cardiac surgery
4. Concomitant surgery, e.g. valve replacement
5. Previous psychiatric illness, e.g. depression, schizophrenia
6. Dialysis-dependent renal failure
7. Q-wave myocardial infarction in the past six weeks
8. Very poor left ventricular function (ejection fraction less than 20%)
9. Illiteracy or non-fluency in English
10. Absence of an acoustic window for transcranial Doppler ultrasound monitoring

Recruitment start date

01/08/2002

Recruitment end date

01/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's Hospital
Department of Cardiac Surgery Blackshaw Road
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

St George's Hospital (UK)

Sponsor details

Blackshaw Road
London
SW17 0QT
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

St George's Hospital Cardiothoracic Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Royal College of Surgeons of England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15019669
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16863773

Publication citations

  1. Motallebzadeh R, Kanagasabay R, Bland M, Kaski JC, Jahangiri M, S100 protein and its relation to cerebral microemboli in on-pump and off-pump coronary artery bypass surgery., Eur J Cardiothorac Surg, 2004, 25, 3, 409-414, doi: 10.1016/j.ejcts.2003.12.018.

  2. Motallebzadeh R, Bland JM, Markus HS, Kaski JC, Jahangiri M, Health-related quality of life outcome after on-pump versus off-pump coronary artery bypass graft surgery: a prospective randomized study., Ann. Thorac. Surg., 2006, 82, 2, 615-619, doi: 10.1016/j.athoracsur.2006.03.081.

Additional files

Editorial Notes

27/11/2015: Publication reference added.