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ISRCTN
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ISRCTN26970041
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ClinicalTrials.gov identifier
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Public title
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Type 2 diabetic patients without coronary artery disease: cardiovascular prognosis
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Scientific title
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Hypotheses, rationale, design, and methods for prognostic evaluation in type 2 diabetic patients with angiographically normal coronary arteries: The MASS IV-DM Trial
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Acronym
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MASS IV DM
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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1. Scientific and Ethics Committee of the Heart Institute (InCor), Hospital of the Faculty of Medicine, University of Sao Paulo, approved on 15/06/2009 (ref: 946/94/56)
2. Institutional Review Board (Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq) approved on 15/06/2009 (ref: 264/94)
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Study design
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Observational longitudinal case-control single-centre study
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Prognosis of coronary artery disease in type 2 diabetic patients
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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03/11/2009
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Anticipated end date
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03/11/2016
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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600
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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1. Microalbuminuria and renal function
2. Stroke
All primary and secondary outcome measures will be assessed every six months for 5 years.
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Sources of funding
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Zerbini Foundation of the Heart Institute, University of São Paulo (Brazil)
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Trial website
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Publications
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Contact name
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Prof
Whady
Hueb
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Address
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Heart Institute
University of São Paulo
Av Dr Eneas de Carvalho Aguiar 44
AB sala 114
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City/town
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Sao Paulo
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Zip/Postcode
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05403000
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Country
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Brazil
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Tel
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+55 11 3069 5032
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Fax
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+55 11 3069 5188
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Email
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whady.hueb@incor.usp.br
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Sponsor
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Zerbini Foundation (Brazil)
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Address
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Heart Institute
University of São Paulo
Av Dr Eneas de Carvalho Aguiar 44
AB sala 114
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City/town
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Sao Paulo
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Zip/Postcode
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05403000
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Country
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Brazil
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Tel
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+55 11 3069 5032
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Fax
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+55 11 3069 5188
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Email
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whady.hueb@incor.usp.br
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Sponsor website:
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http://www.incor.usp.br
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Date applied
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06/10/2009
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Last edited
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20/10/2009
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Date ISRCTN assigned
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20/10/2009
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