Evaluation of cardiac biomarker elevation after percutaneous coronary intervention or coronary artery bypass graft
| ISRCTN | ISRCTN09454308 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09454308 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/03/2012
- Registration date
- 08/05/2012
- Last edited
- 16/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Patients with blockages of the coronary arteries may develop symptoms related to the altered blood supply to the heart muscle, such as chest pain (angina). Most patients with angina can relieve their symptoms with medication. Others may need surgery such as bypass surgery or angioplasty with stent placement, which improve symptoms but may lead to heart injury. This injury can be assessed by laboratory measurement of substances released from the heart. The two most important substances that are measured routinely after these procedures are troponin and creatine-kinase MB. The release of these substances is quite a common event. Although the release of high levels of these substances may indicate heart injury during the procedure, the normal levels of release are not completely understood. It is not known whether this release indicates heart injury or is just related to the procedure itself. The aim of this study is to investigate the relationship between heart injury and levels of troponin and creatine-kinase MB in patients undergoing heart surgery.
Who can participate?
Patients with coronary artery disease and angina who are undergoing heart surgery
What does the study involve?
Participants are assessed using a cardiac magnetic resonance (CMR) scan to look for areas of heart injury. They then undergo heart surgery. After these procedures, blood samples are collected and levels of troponin and creatine-kinase MB are measured. After the participants recover from the procedure they undergo a second CMR. The findings of the second CMR are compared with the first and the new areas of heart injury are compared with the levels of troponin and creatine-kinase MB.
What are the possible benefits and risks of participating?
This study will improve our understanding of what happens to the heart during these procedures and hopefully will help us to identify heart injury during such procedures.
Where is the study run from?
Heart Institute (InCor) Instituto do Coração – HCFMUSP (Brazil)
When is the study starting and how long is it expected to run for?
March 2012 to March 2017
Who is funding the study?
1. Zerbini Foundation (Brazil)
2. Fundação de Amparo à Pesquisa do Estado de São Paulo (Brazil)
Who is the main contact?
Prof. Whady Hueb
Contact information
Scientific
Unidade Projeto MASS
Heart Institute (InCor) Instituto do Coração - HCFMUSP
Av. Dr. Enéas de Carvalho Aguiar, Nº 44 - Bloco I - AB sala 114
Sao Paulo
05403-000
Brazil
Study information
| Study design | Single-center prospective non-randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please contact Prof Whady Hueb (whady.hueb@incor.usp.br) to request a patient information sheet |
| Scientific title | Prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifested myocardial infarction: a comparative analysis of biomarkers and cardiac magnetic resonance |
| Study hypothesis | The release of enzyme markers of myocardial cells allows the diagnosis of acute myocardial infarction (AMI), when the levels of Creatine Kinase-MB (CK-MB) or troponin are elevated up to 3 times above the established standard for percutaneous interventions (PCI) and up to 5 times for surgical revascularization - coronary artery bypass graft (CABG) even in the absence of electrocardiographic changes or clinical symptoms. There is doubt about cut-off levels of these biomarkers that lead to myocardial fibrosis, left ventricular dysfunction, and one that implies a bad prognosis in a long-term follow-up. The hypothesis is that the releasing of biomarkers does not necessarily lead to myocardial fibrosis or left ventricular dysfunction; and the cut-off levels to define periprocedural AMI would be different from the ones established in current guidelines. |
| Ethics approval(s) | Institutional Review Board, 15/12/2011, ref: SDC 3736/11/154 |
| Condition | Patients with multivessel coronary artery disease and stable angina with formal indication for revascularization procedures |
| Intervention | Percutaneous coronary intervention using stents - 5 year follow-up Coronary artery bypass graft with cardiopulmonary bypass (on-pump) - 5 year follow-up Coronary artery bypass graft without cardiopulmonary bypass (off-pump) - 5 year follow-up |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Overall death in a 5-year follow-up |
| Secondary outcome measures | 1. Levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis 2. Left ventricle ejection disfunction assessed by CMR |
| Overall study start date | 01/03/2012 |
| Overall study end date | 01/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 155 |
| Participant inclusion criteria | 1. Stable angina 2. Multi-vessel coronary artery disease 3. Preserved left ventricular function 4. Formal indication to revascularization procedures (PCI or CABG) |
| Participant exclusion criteria | 1. Recent myocardial infarction (≤6 months) 2. Signs of manifest or suspected infections 3. Rheumatologic disease activity 4. Chronic renal failure (creatinine level >2.0mg/dL) 5. Recent (≤ 6 months) pulmonary embolism or venous thromboembolism 6. Does not sign the consent form 7. Contraindication for the use of glycoprotein IIb/IIIa inhibitors 8. Cardiac magnetic resonance (CMR) examination, for example, a person with a pacemaker or severe claustrophobia |
| Recruitment start date | 25/04/2012 |
| Recruitment end date | 23/07/2014 |
Locations
Countries of recruitment
- Brazil
Study participating centre
05403000
Brazil
Sponsor information
Charity
Avenida Dr Eneas de Carvalho Aguiar 44
AB 114 Cerqueira Cesar
Sao Paulo
05403000
Brazil
| Website | http://www.incor.usp.br |
|---|---|
"ROR" |
https://ror.org/003c2h870 |
Funders
Funder type
Charity
No information available
Private sector organisation / Local government
- Alternative name(s)
- São Paulo Research Foundation, State of São Paulo Research Foundation, Foundation for Research Support of the State of São Paulo, FAPESP
- Location
- Brazil
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2016 | Yes | No | |
| Results article | results | 21/11/2017 | Yes | No | |
| Results article | results | 29/12/2017 | Yes | No | |
| Results article | results | 06/12/2020 | 07/12/2020 | Yes | No |
| Other publications | subanalysis in patients with stable coronary artery disease with and without type 2 diabetes | 09/07/2024 | 16/07/2024 | Yes | No |
Editorial Notes
16/07/2024: Publication reference and total final enrolment added.
07/12/2020: Publication reference added.
15/02/2018: Publication reference added.
14/02/2018: Publication reference added.
13/07/2016: Plain English summary added.
12/07/2016: Publication reference added.
