Plain English Summary
Background and study aims
Acute coronary syndromes are conditions where decreased blood flow in the blood vessels supplying the heart (the coronary arteries) cause part of the heart muscle to be unable to function properly or to die. For example, angina is chest pain that occurs when the coronary arteries become hardened and narrowed, restricting the heart’s blood supply. A myocardial infarction (heart attack) occurs when the heart’s blood supply is suddenly blocked, usually by a blood clot. In the last 20 years stenting (also known as Percutaneous Coronary intervention or PCI) has revolutionised the treatment of angina and heart attack, improving prognosis and symptoms for thousands of patients. The procedure involves widening the coronary artery using a balloon catheter then placing a small mesh tube called a stent into the artery. Day case stenting is of increasing interest as it has been shown to be safe and cost saving. Patients are monitored for 6 hours after stenting, after which time complications have been shown to be very rare. However, occasionally a patient may suffer a heart attack following stenting, mainly due to a complication of the procedure. Sometimes this can be ‘silent’, i.e. without any symptoms. Special blood tests for biomarkers can be used to detect injury following stenting and have been of increasing interest over the last few years. An ideal biomarker would indicate if there was damage to the heart very soon after the injury and help to guide decisions with regard to patient discharge. Therefore, the aim of this study is to investigate the levels of such biomarkers during and after stenting to see if they can be used to predict adverse patient outcomes.
Who can participate?
Any patient over 18 years old presenting for day case stenting for chronic stable angina, acute coronary syndrome or myocardial infarction
What does the study involve?
Patients have blood samples taken to analyse for biomarkers at 0, 4, 6 and 24 hours after stenting, and receive a telephone call at 30 days and one year after stenting to assess for any adverse outcomes (e.g., myocardial infarction, stroke, heart failure, death).
What are the possible benefits and risks of participating?
There is no immediate direct benefit from taking part in this study as the results will not be available until the study finishes. The information obtained will help improve our understanding of heart muscle damage during stenting procedures which it is hoped will eventually lead to improvements in this treatment for other future patients. You will be required to provide a sample of blood on three occasions. Occasionally, individuals may develop some local bruising and/or discomfort at the site of blood sampling.
Where is the study run from?
Craigavon Area Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2010 to July 2012
Who is funding the study?
Randox Laboratories (UK)
Who is the main contact?
Dr Michael Connolly
michael.connolly@southerntrust.hscni.net
Study website
Contact information
Type
Scientific
Contact name
Dr Michael Connolly
ORCID ID
Contact details
Cardiovascular Research Unit
Craigavon Area Hospital
Armagh
Portadown
BT68 5QQ
United Kingdom
+44 (0)28 3833 4444 ext 2364
michael.connolly@southerntrust.hscni.net
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1.1 16/02/2010
Study information
Scientific title
Predicting safe patient discharge post percutaneous revascularisation: an observational study
Acronym
Study hypothesis
1. Normal levels of novel biomarkers of myocardial necrosis at 6 hours post procedure (fatty acid binding protein [FABP], glycogen phosphorylase isoenzyme BB [GPBB], myoglobin/carbonic anhydrase 3 ratio, high-sensitivity [hs] troponin T) will predict normal 24-hour 4th generation Troponin T and creatine kinase (CK) levels post percutaneous revascularisation. This represents the null hypothesis. This will also predict those at low risk of cardiac events at 30 days and 1 year.
2. Prediction of elevated 24-hour troponin and CK levels by novel biomarkers of myocardial necrosis will be additive to that provided by clinical factors alone.
Ethics approval(s)
Office for Research Ethics Committees Northern Ireland (ORECNI), 08/03/2010, REC ref: 10/NIR03/2
Study design
Cohort observational study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ischaemic heart disease patients presenting for PCI
Intervention
Patients will have blood samples for biomarkers taken at 0, 4, 6 and 24 hours following stenting, and receive a telephone call at 30 days and one year following stenting to assess for adverse outcomes.
Intervention type
Other
Primary outcome measure
Post procedure biomarker elevation diagnostic for Type 4a myocardial infarction
Secondary outcome measures
1. Major Adverse Cardiac Events (MACE) at 30 days and 1 year
1.1. Myocardial infarction
1.2. Stroke
1.3. Target vessel revascularisation
1.4. Heart failure hospitalisation
1.5. Death
Overall study start date
01/04/2010
Overall study end date
01/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 18 at enrolment
2. Undergoing Percutaneous Coronary Intervention (PCI) for chronic stable angina or as part of staged procedure following acute coronary syndrome (ACS)/myocardial infarction (MI) (index event >14 days previously)
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
275
Participant exclusion criteria
1. Terminal malignancy
2. Inability to give informed consent due to impaired mental capacity
3. ACS/chest pain at admission/MI within last 14 days
Recruitment start date
01/04/2010
Recruitment end date
01/07/2012
Locations
Countries of recruitment
Northern Ireland, United Kingdom
Study participating centre
Craigavon Area Hospital
Portadown
BT68 5QQ
United Kingdom
Sponsor information
Organisation
Randox Laboratories (UK)
Sponsor details
55 Diamond Road
Crumlin
Antrim
BT29 4QY
United Kingdom
-
maryjo.kurth@randox.com
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Randox Laboratories (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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|