Condition category
Circulatory System
Date applied
30/04/2012
Date assigned
11/06/2012
Last edited
07/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2010

Overall trial end date

01/07/2012

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/04/2016: Plain English summary added.