Type 2 diabetic patients without coronary artery disease: cardiovascular prognosis

Hypotheses, rationale, design, and methods for prognostic evaluation in type 2 diabetic patients with angiographically normal coronary arteries: the MASS IV-DM trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN26970041

Enrollment

600

Registered

2009-10-20

Start date

2010-03-31

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prognosis of coronary artery disease in type 2 diabetic patients Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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 coronar

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
1. Microalbuminuria and renal function 2. Stroke All primary and secondary outcome measures will be assessed every six months for 5 years.	—

Primary

Measure	Time frame
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.	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026