Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/04/2011
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

Dr Francisco Leyva

ORCID ID

Contact details

Consultant Cardiologist
Good Hope Hospital NHS Trust
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0523154398

Study information

Scientific title

Acronym

Study hypothesis

Study the efficacy of the intravascular as compared to intramuscular administration of autologous bone marrow in the reduction of scar tissue in the heart muscle and in the improvement of segmental contactile function

Ethics approval

Not provided at time of registration

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

Surgery: Coronary artery bypass grafting (CABG)

Intervention

[A] Control group receiving only myocardial revascularisation
[B] Direct injection into the scar muscle of self bone marrow mononuclear cells in addition to myocardial revascularisation
[C] Intravascular administration of self bone marrow into the graft used for myocardial revascularisation

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Functional improvement, and reduction in size of scar areas. The study will also establish whether the number and the type of transplanted bone marrow mononuclear cells is correlated with the recovery of contractile function by performing multiple linear regression analysis.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/04/2004

Overall trial end date

07/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing coronary bypass graft surgery aged between 18 and 80. Estimated 30 patients per group in order to detect significance

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Estimated 30 patients per group

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

07/04/2004

Recruitment end date

07/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Cardiologist
Birmingham
B75 7RR
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Good Hope Hospital NHS Trust (UK)

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18711405

Publication citations

  1. Results

    Ang KL, Chin D, Leyva F, Foley P, Kubal C, Chalil S, Srinivasan L, Bernhardt L, Stevens S, Shenje LT, Galiñanes M, Randomized, controlled trial of intramuscular or intracoronary injection of autologous bone marrow cells into scarred myocardium during CABG versus CABG alone., Nat Clin Pract Cardiovasc Med, 2008, 5, 10, 663-670, doi: 10.1038/ncpcardio1321.

Additional files

Editorial Notes