Plain English Summary
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. Diabetes can lead to atherosclerosis, a disease where obstructive plaques build up inside the arteries. This disease may affect the vessels that supply the heart muscle, called the coronary arteries. Patients with such plaques may or may not have symptoms such as chest pain, which usually occurs during exercise or emotional stress and improves with rest. Although diabetes may lead to coronary obstructive plaques, it is still not completely known why some patients do not have this disease. The aim of this study is therefore to study the changes of the coronary arteries and heart function in patients with type 2 diabetes and no evidence of coronary artery disease.
Who can participate?
Patients with type 2 diabetes and no evidence of coronary artery disease
What does the study involve?
Participants are assessed for the development of coronary atherosclerosis using angiograms (a type of X-ray to examine blood vessels) and coronary-artery calcium scans at the start of the study and after 5 years of follow-up. In addition, the incidence of cardiovascular events, such as death, myocardial infarction (heart attack) and revascularization procedures are tracked, along with the functioning of the organs that are affected by diabetes, such as the kidneys. In addition, other heart disease risk factors that may play a role in coronary disease are investigated.
What are the possible benefits and risks of participating?
With this study, we hope to better understand the factors that may be associated with plaque formation in the coronary arteries of diabetic patients.
Where is the study run from?
University of São Paulo (Brazil)
When is the study starting and how long is it expected to run for?
November 2009 to November 2016
Who is funding the study?
Zerbini Foundation of the Heart Institute, University of São Paulo (Brazil)
Who is the main contact?
Prof. Whady Hueb
mass@incor.usp.br
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
+55 (0)11 2661 5032
mass@incor.usp.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Hypotheses, rationale, design, and methods for prognostic evaluation in type 2 diabetic patients with angiographically normal coronary arteries: the MASS IV-DM trial
Acronym
MASS IV DM
Study hypothesis
The aim of the MASS IV-DM Trial is to compare the clinical data, laboratory profile, and angiographic evolution at baseline with that at 5-year follow-up in patients with type 2 diabetes who have angiographically normal coronary arteries.
Ethics approval
1. Scientific and Ethics Committee of the Heart Institute (InCor), Hospital of the Faculty of Medicine, University of Sao Paulo, 15/06/2009, ref: 946/94/56
2. Institutional Review Board (Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq), 15/06/2009, ref: 264/94
Study design
Observational longitudinal case-control single-centre study
Primary study design
Observational
Secondary study design
Case-control 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
Prognosis of coronary artery disease in type 2 diabetic patients
Intervention
This study is an observational case-control study with 5 years follow-up.
Diabetic patients with clinically suspected or electrocardiographically documented myocardial ischaemia will undergo coronary angiography, coronary artery calcium scan, doppler echocardiography, arterial stiffness evaluation, laboratory measurements and genetic analysis.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Incidence of major cardiovascular events (myocardial infarction, death and heart failure).
All primary and secondary outcome measures will be assessed every six months for 5 years.
Secondary outcome measures
1. Microalbuminuria and renal function
2. Stroke
All primary and secondary outcome measures will be assessed every six months for 5 years.
Overall trial start date
03/11/2009
Overall trial end date
03/11/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Type 2 diabetic patients (both males and females) with a clinical suspicion of coronary insufficiency and electrocardiographic evidence of myocardial ischaemia who have normal coronary angiographies and ventricular function.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. Age under 18 years
2. Suspected or planned pregnancy
3. Cardiomyopathy
4. Coronary artery disease
5. Heart failure
6. Diabetic renal dysfunction
7. Neoplasy
8. Unable to give informed consent
Recruitment start date
31/03/2010
Recruitment end date
27/10/2011
Locations
Countries of recruitment
Brazil
Trial participating centre
University of São Paulo
Sao Paulo
05403000
Brazil
Sponsor information
Organisation
Zerbini Foundation (Brazil)
Sponsor details
Heart Institute
University of São Paulo
Av Dr Eneas de Carvalho Aguiar 44
AB sala 114
Sao Paulo
05403000
Brazil
+55 (0)11 3069 5032
whady.hueb@incor.usp.br
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
Zerbini Foundation of the Heart Institute, University of São Paulo (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26195004