Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/10/2009
Date assigned
20/10/2009
Last edited
13/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.incor.usp.br

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26195004

Publication citations

Additional files

Editorial Notes

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