Condition category
Circulatory System
Date applied
27/07/2009
Date assigned
14/10/2009
Last edited
31/07/2014
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
R.Ascione@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CS/2008/3027

Study information

Scientific title

Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure: a randomised blinded controlled trial

Acronym

TransACT 2

Study hypothesis

The aim of this study is to determine the effects of CD133+ autologous stem cells transplantation in and around asynergic non-viable left ventricular (LV) segments in patients with dilated ischaemic heart disease undergoing left ventricular reshaping surgery and coronary artery bypass graft (CABG).

Ethics approval

NHS Southmead Research Ethics Committee, 20/07/2005, ref: 05/K2002/49

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

Eligible patients undergoing SVR surgery will be allocated to either:
1. Intervention group: SVR surgery and transplantation of autologous CD133+
2. Control group: SVR surgery and injection of placebo, i.e. autologous plasma

Please use 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
United Kingdom
Tel: +44 (0)117 342 3398
Email: j.taylor@bristol.ac.uk

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Regional LV thickening of the 'affected' segments 6 months after surgery, i.e. end systolic thickness minus end diastolic thickness (millimetres). Affected segments will be those scored on the cardiac MRI taken 3 - 5 days after surgery, as 1 - 5 (dysfunctional) on a 5-point scale. Affected segments will be the segments which the surgeons aims to inject with stem cells or plasma. Measured at baseline (3 - 5 days post-operatively) and 6 months follow-up.

Secondary outcome measures

1. Mid-term generic and cardiac-specific health status and quality of life, measured at baseline and 6 months follow-up
2. End systolic volume and stroke volume quantified by cardiac MRI, measured at baseline (3 - 5 days post-operatively) and 6 months follow-up
3. Myocardial injury throughout the duration of the study by measuring troponin I levels (24 hours pre-operatively, surgery, 4, 12, 24 hours post-operatively, 6 weeks and 6 months follow-up)

Overall trial start date

01/08/2009

Overall trial end date

01/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Previous anterior myocardial infarction (with evidence of large surgically excludible scar at cardiac magnetic resonance imaging [MRI])
2. Significant LV dilation (left ventricular end-systolic volume index [LVESVI] greater than or equal to 60 ml/m^2
3. Left ventricular ejection fraction less than or equal to 35%
4. New York Heart Association (NYHA) class III/IV and one episode of congestive heart failure (CHF) requiring medical attention
5. Elective left ventricular restoration surgery indicated
6. Elective CABG indicated to bypass stenoses or occlusions of coronary arteries
7. Patient aged 16 years or over and under 80 years old, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Severe acute renal failure requiring dialysis or serum creatinine greater than or equal to 200 mmol/L
2. Atrial fibrillation
3. Malignancy
4. Debilitating neurological disease
5. Emergency operation for unstable angina
6. Previous cardiac surgery/sternotomy
7. Concomitant valve procedures
8. History of significant ventricular arrhythmias
9. History of pacemaker and/or defibrillator insertion
10. Right ventricular (RV) failure
11. Pulmonary hypertension greater than 60 mmHg (angiogram or Elixis)
12. Known active infection
13. Chronic inflammatory disease
14. Contraindication for bone marrow aspiration
15. Female subjects of childbearing potential

Recruitment start date

01/08/2009

Recruitment end date

01/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 7, Research Floor
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

Research and Effectiveness Department
Education Centre
Level 3
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
jake.hartley@ubht.nhs.uk

Sponsor type

Government

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit

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