Prediction of cardiovascular risk in chronic coronary syndrome using cardiac troponin
| ISRCTN | ISRCTN15620297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15620297 |
| Secondary identifying numbers | DL-21-016 |
- Submission date
- 23/11/2022
- Registration date
- 30/11/2022
- Last edited
- 01/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
We have recently shown that a blood test called troponin can predict the severity of a type of heart disease called coronary artery disease on a CT scan in patients who have symptoms suggestive of angina. However we think that troponin could also be able to tell us which patients at the highest chance of future heart attacks or dying from cardiovascular disease. Measuring troponin in patients with coronary artery disease could help prioritise tests and intensify medical treatments in patients who will benefit the most.
Who can participate?
Every patient who attends hospital for an angiogram dye test of their heart arteries for investigation of suspected angina at the Royal Infirmary of Edinburgh, Scotland over a 6 year period from 31/July/2015.
What does the study involve?
Troponin will be measured on the same blood samples that are already routinely taken before the procedure. We will test whether troponin levels can predict the severity of heart disease seen on the angiogram and will look to see if troponin can predict risk of heart attacks or death in the future. This study is being funded by a grant from the British Heart Foundation. The lead contact for this study is Professor Nicholas Mills, Consultant Cardiologist and Professor of Cardiology, University of Edinburgh and NHS Lothian (Nick.Mills@ed.ac.uk)
What are the possible benefits and risks of participating?
None.
Where is the study run from?
Royal Infirmary of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
July 2015 to July 2021
Who is funding the study?
British Heart Foundation (UK)
Medical Research Council (UK)
Who is the main contact?
Dr Ryan Wereski, ryan.wereski@ed.ac.uk
Prof Nick Mills, Nick.Mills@ed.ac.uk
Contact information
Public
Centre for Cardiovascular Science
Chancellors Building SU305
Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
 ORCID ID |
0000-0001-6485-453X |
|---|---|
| Phone | +44 1312426431 |
| Ryan.Wereski@ed.ac.uk |
Scientific
Centre for Cardiovascular Science
Chancellors Building SU305
Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
| Phone | +44 1312426431 |
|---|---|
| Ryan.Wereski@ed.ac.uk |
Principal Investigator
Centre for Cardiovascular Science
Chancellors Building SU305
Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
| Phone | +44 1312426431 |
|---|---|
| Nick.Mills@ed.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not applicable - individual patient consent was not required for this study |
| Scientific title | Myocardial Injury in patients attending for Coronary Angiography |
| Study acronym | MICA |
| Study objectives | We hypothesise that in a population of patients attending for elective coronary angiography, that the concentration of high-sensitivity cardiac troponin will: 1. Predict the prevalence and extent of obstructive coronary artery disease; 2. Predict those patients who are at the highest risk of future adverse clinical events including all-cause mortality, cardiovascular death, and myocardial infarction |
| Ethics approval(s) | Approved 20/08/2015, East of Scotland Research Ethics Committee (Ninewells Hospital & Medical School, Tayside Medical Science Centre (TASC), Residency Block, Level 3, George Pirie Way, Dundee, DD1 9SY, UK; +44 (0)1382 383871; tay.eosres@nhs.scot), ref: 20/ES/0061 |
| Health condition(s) or problem(s) studied | Patients with suspected or known atherosclerotic coronary disease and chronic coronary syndrome attending for elective coronary angiography |
| Intervention | This is an observational study which aims to evaluate whether concentrations of high-sensitivity troponin I are associated with severity of coronary artery disease and clinical outcomes in patients attending for elective coronary angiography for investigation of suspected chronic coronary syndrome. All participants referred for elective coronary angiography for investigation of chronic coronary syndrome at the Royal Infirmary of Edinburgh will be enrolled if routine clinical pre-procedure were taken on the day of the procedure. This study makes use of routinely collected electronic healthcare records and requires no direct involvement from participants. High-sensitivity cardiac troponin will be measured prospectively in the background on blood sample excess to clinical requirement. Attending clinicians will be blinded to the result. Participants care will not be directly impacted by participation. All participants will be followed up until 31/07/2021. Coronary artery disease severity will be determined by the attending interventional cardiologist at the time of angiography and recorded prospectively in a clinical reporting database (TOMCAT, Philips Cardiovascular Information Management System, Netherlands) before data extraction. The maximal stenosis will be used to define the severity of coronary disease in each major epicardial coronary artery. Obstructive coronary artery disease is defined by convention as a stenosis ≥70% in one or more major epicardial coronary artery or a stenosis ≥50% in the left main stem. Coronary artery disease severity will also be also evaluated using the hierarchical Duke Prognostic Index, which categorizes coronary disease according to extent, location, and stenosis severity. Routine electronic healthcare data and national registries will be used follow-up the study population for clinical outcome events. All deaths and hospital admissions are recorded on the Register of Deaths in Scotland and the Scottish Morbidity Record (SMR), respectively. |
| Intervention type | Other |
| Primary outcome measure | Non-fatal myocardial infarction or cardiovascular death up to study end date. This is defined using the International Classification of Disease (ICD)-10 codes of I21 or I22 for myocardial infarction and I00 to I99 inclusive for cardiovascular death. Measured using patient records. |
| Secondary outcome measures | All-cause mortality and coronary revascularization, defined as percutaneous coronary intervention or coronary artery bypass surgery and within 30 days. Measured using patient records. |
| Overall study start date | 31/07/2015 |
| Completion date | 31/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 4200 |
| Total final enrolment | 4917 |
| Key inclusion criteria | 1. Elective angiography for evaluation of chronic coronary disease 2. Pre-procedure blood samples obtained on the same day as the procedure 3. Permanently resident in Scotland |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 31/07/2016 |
| Date of final enrolment | 31/07/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Larbert
FK5 4WR
United Kingdom
Melrose
TD6 9BS
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Livingston
Lothian
EH54 6PP
United Kingdom
Sponsor information
University/education
QMRI
47 Little France Crescent
Edinburgh
EH16 4TJJ
Scotland
United Kingdom
| Phone | +44 1312426431 |
|---|---|
| dataloch@ed.ac.uk | |
| Website | http://accord.scot/research-access/sponsorship |
"ROR" |
https://ror.org/01x6s1m65 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Initially, study findings will be published in a peer-reviewed medical journal and presented at a scientific conference. In the past we have worked closely with the media team at the British Heart Foundation, as well as the media team at the University of Edinburgh to help publicise research within the Centre for Cardiovascular Sciences, and disseminate important results. We also publish summary results on the University website for interested members of the public to view. The strategy for this project will follow a similar pattern. |
| IPD sharing plan | This project was supported by University of Edinburgh/NHS Lothian DataLoch. Pseudoanonymised data can be accessed by approved researchers, subject to individual project application, and ethical and governance approval. The privacy notice can be found at https://dataloch.org/privacy-notice. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 08/08/2023 | 01/08/2023 | Yes | No |
Editorial Notes
01/08/2023: Publication reference added.
30/11/2022: Trial's existence confirmed by Public Benefit and Privacy Panel for Health and Social Care.
