Condition category
Circulatory System
Date applied
14/03/2012
Date assigned
08/05/2012
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Whady Hueb

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

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. Our 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

Institutional Review Board, 15/12/2011, ref: SDC 3736/11/154

Study design

Single-center prospective non-randomized interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please contact Prof Whady Hueb (whady.hueb@incor.usp.br) to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2012

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

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

Trial participating centre

Zerbini Foundation [Fundacao Zerbini]
Sao Paulo
05403000
Brazil

Sponsor information

Organisation

Zerbini Foundation [Fundação Zerbini] (Brazil)

Sponsor details

Avenida Dr Eneas de Carvalho Aguiar 44
AB 114 Cerqueira Cesar
Sao Paulo
05403000
Brazil

Sponsor type

Charity

Website

http://www.incor.usp.br

Funders

Funder type

Charity

Funder name

Zerbini Foundation (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fundação de Amparo à Pesquisa do Estado de São Paulo

Alternative name(s)

São Paulo Research Foundation, Foundation for Research Support of the State of São Paulo, State of São Paulo Research Foundation, FAPESP

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Brazil

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26912303

Publication citations

Additional files

Editorial Notes

13/07/2016: Plain English summary added. 12/07/2016: Publication reference added.