Condition category
Circulatory System
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
07/03/2014
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

Prof Derek Yellon

ORCID ID

Contact details

The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
d.yellon@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4058

Study information

Scientific title

A multicentre randomised interventional treatment trial to explore the mechanistic pathway of ischaemic preconditioning and postconditioning in the clinical settings of myocardial ischaemia-reperfusion injury

Acronym

ACE - CABG/PPCI

Study hypothesis

The aim of the study is use pharmacological agents that have been shown to activate survival kinases and inhibit mPTP opening to explore the mechanistic pathway of ischaemic preconditioning and postconditioning in the clinical settings of myocardial ischaemia-reperfusion injury. Patients who are due to undergo planned cardiac surgery will be recuited to receive an interventional agent. These patients will be randomised and compared against a group of controls. Blood tests would be taken post-operatively to assess the primary end points.

Ethics approval

The Joint UCL/UCLH Committees on the Ethics of Human Research Committee (Alpha) approved on the 23/11/2006 (ref: 06/Q0502/83)

Study design

Multicentre randomised interventional treatment 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 below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

1. Intervention 1: Cyclosporin A at dose of 2.5 mg/kg; diluted in 100 ml of normal saline. Once only dose given over 30 minutes prior to surgery.
2. Intervention 2: Atorvastatin at a dose of 160 mg; given on the morning of surgery and a second dose of 160 mg repeated 24 hours later
3. Intervention 3: Erythropoietin at a dose of 50,000 IU; given as an infusion of 50 ml over 30 minutes prior to revascularisation. A second dose is repeated 24 hours later.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Serum cTnT and CK-MB (bloods taken before intervention and at 6, 12, 24, 48 and 72 hours post-intervention).

Secondary outcome measures

1. Inotropic score: calculated using the maximum inotropic dose used on day 1 post-op
2. Ventilation time: assessed from the time of admission into ITU to the time of extubation
3. ITU stay: assessed from the time of admission into ITU to the time of discharge from the unit

Overall trial start date

01/06/2007

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients experiencing an event or procedure which will bring about myocardial injury:
1. Coronary artery bypass surgery +/- valve surgery
2. Primary angioplasty for ST elevation myocardial infarction
3. Thrombolysis for ST elevation myocardial infarction
4. Non-ST elevation myocardial infarction
5. High risk and undergoing percutaneous coronary intervention
6. Aged 18 - 85 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 400

Participant exclusion criteria

1. Significant co-morbidity
2. Known intolerance to trialled intervention
3. Renal/liver failure
4. In patients undergoing an elective procedure-chest pain within the last 3 days, lack of consent

Recruitment start date

01/06/2007

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Hatter Institute for Cardiovascular Studies
London
WC1E 6DB
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

UCL Biomedicine Research & Development Unit
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24488610

Publication citations

  1. Results

    Hausenloy Dj, Kunst G, Boston-Griffiths E, Kolvekar S, Chaubey S, John L, Desai J, Yellon D, The effect of cyclosporin-A on peri-operative myocardial injury in adult patients undergoing coronary artery bypass graft surgery: a randomised controlled clinical trial., Heart, 2014, 100, 7, 544-549, doi: 10.1136/heartjnl-2013-304845.

Additional files

Editorial Notes