Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
26/07/2016
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

Mr David Varghese

ORCID ID

Contact details

Level D
East Wing
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)7855 495450
dvarghese@btinternet.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0231134600

Study information

Scientific title

A pilot study to evaluate the efficacy of combined transplantation of progenitor cells and coronary artery bypass grafting (TOPCABG)

Acronym

Study hypothesis

Can the transplanted progenitor cells promote improvements in myocardial 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

Not available in web format, please use contact details to request a participant information sheet

Condition

Surgery: Coronary artery bypass grafting (CABG)

Intervention

Randomised controlled trial - 5 recipients receiving stem cells and 5 control patients receiving heparinised saline

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Improvements in myocardial function, regional wall motion and myocardial perfusion

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

10 patients undergoing coronary artery bypass grafting

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/2004

Recruitment end date

01/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Southampton University Hospitals 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

Publication citations

Additional files

Editorial Notes

26/07/2016: No publications found, verifying study status with principal investigator.