Condition category
Circulatory System
Date applied
01/05/2008
Date assigned
10/07/2008
Last edited
04/04/2013
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 Raimondo Ascione

ORCID ID

Contact details

Level 7
Research Floor
University of Bristol
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sponsor ref: CS/2005/2031

Study information

Scientific title

Acronym

TransACT

Study hypothesis

The transplantation of bone marrow derived CD133+ autologous stem cells in and around large asynergic scarred areas of the heart will induce neoangiogenesis and neomyogenesis restoring local viability and contractility. CD133+ transplantation may also prevent left ventricular (LV) remodelling, improving mid-term quality of life in patients with ischemic non-dilated cardiomyopathy undergoing coronary surgery.

Ethics approval

NHS Southmead Research Ethics Committee (ref: 05/Q2002/50). Date of approval: 20/07/2005. Amendment approved on 06/08/2007.

Study design

Double-blind, randomised, placebo-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 the contact details provided in the Interventions field to request a patient information sheet.

Condition

Cardiac disease/ coronary surgery

Intervention

Experimental intervention: Injection of enriched autologous CD133+ stem cells derived from bone marrow, suspended in autologous plasma
Comparator intervention: Injection of autologous plasma

Please use the following contact details to request a patient information sheet:
Dr Jodi Taylor
Clinical Trials Co-ordinator
Bristol Heart Institute
University of Bristol
Level 7, Bristol Royal Infirmary
Bristol
BS2 8HW, UK
Tel: +44 (0)117 928 3398
Email: j.taylor@bristol.ac.uk

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Regional LV thickening of the injected segments of the left ventricle 6 months after surgery measured by cardiac MRI. The use of MRI will also allow us to ascertain the reasons for any observed changes in wall thickening at the injected sites at 6 months by comparing the transmural distribution of viable myocardium and scar before and after surgery.

Secondary outcome measures

The following outcomes will be measured pre-operatively and at 6 months after surgery:
1. Scar distribution and the viability of the myocardium with MRI
2. LV segmental and global function with echocardiography
3. Mid-term generic and cardiac specific health status and quality of life. These will be assessed by the disease-specific Coronary Revascularisation Outcome Questionnaire, the Minnesota Living with Heart Failure Questionnaire and the 36-item Short Form health survey (SF-36)
4. Myocardial injury throughout the entire study period by measuring troponin I levels

Overall trial start date

01/06/2008

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients of either sex, aged 16 years or over and under 80 years
2. Recent (>10 days and 3 months) anterior ST-Segment Elevation Myocardial Infarction (STEMI) who have not undergone primary angioplasty
3. Cardiac magnetic resonance imaging (MRI) documented anterior myocardial infarction (MI) with a transmurality of >= 50% wall thickness in at least 1 segment of the LAD territory
4. Requirement for coronary artery bypass graft (CABG) alone to bypass stenoses or occlusions of the left anterior descending artery (LAD) territory and any other territory as dictated by baseline coronary angiography
5. Absence of LV dilation (LV end systolic volume index <60 ml/m^2)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 (30 in each group)

Participant exclusion criteria

1. Presence of cardiogenic shock or presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
2. Cardiac MRI documented MI transmurality of <50% wall thickness in all 7 segments of the LAD territory
3. Presence of LV dilatation (LV end systolic volume index >60 ml/m^2)
4. Cardiomyopathy secondary to a reversible cause
5. Known active infection
6. Chronic inflammatory disease
7. Serum creatinine >= 200 mmol/L
8. Contraindications for bone marrow aspiration
9. Female subjects of childbearing potential
10. Emergency operation for unstable angina
11. History of pace-maker or defibrillator insertion

Recruitment start date

01/06/2008

Recruitment end date

01/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 7, Research Floor
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

United Bristol Healthcare NHS Trust (UK)

Sponsor details

UBHT Research and Effectiveness Department
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 342 0233
jake.hartley@ubht.nhs.uk

Sponsor type

Government

Website

http://www.ubht.nhs.uk

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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