Type 2 diabetic patients without coronary artery disease: cardiovascular prognosis

ISRCTN ISRCTN26970041
DOI https://doi.org/10.1186/ISRCTN26970041
Secondary identifying numbers N/A
Submission date
06/10/2009
Registration date
20/10/2009
Last edited
13/07/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Whady Hueb
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

Phone +55 (0)11 2661 5032
Email mass@incor.usp.br

Study information

Study designObservational longitudinal case-control single-centre study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleHypotheses, rationale, design, and methods for prognostic evaluation in type 2 diabetic patients with angiographically normal coronary arteries: the MASS IV-DM trial
Study acronymMASS IV DM
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedPrognosis of coronary artery disease in type 2 diabetic patients
InterventionThis 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 typeOther
Primary outcome measureIncidence 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 measures1. Microalbuminuria and renal function
2. Stroke

All primary and secondary outcome measures will be assessed every six months for 5 years.
Overall study start date03/11/2009
Completion date03/11/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants600
Key inclusion criteriaType 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.
Key exclusion criteria1. 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
Date of first enrolment31/03/2010
Date of final enrolment27/10/2011

Locations

Countries of recruitment

  • Brazil

Study participating centre

University of São Paulo
Sao Paulo
05403000
Brazil

Sponsor information

Zerbini Foundation (Brazil)
Other

Heart Institute
University of São Paulo
Av Dr Eneas de Carvalho Aguiar 44
AB sala 114
Sao Paulo
05403000
Brazil

Phone +55 (0)11 3069 5032
Email whady.hueb@incor.usp.br
Website http://www.incor.usp.br
ROR logo "ROR" https://ror.org/003c2h870

Funders

Funder type

Other

Zerbini Foundation of the Heart Institute, University of São Paulo (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/07/2015 Yes No

Editorial Notes

13/07/2016: Plain English summary added.
10/03/2016: Publication reference added.