"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population (PRECISED)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Coronary Artery Disease; Acute Coronary Syndrome/ Myocardial Infarction; Non Alcoholic Fatty Liver Disease; Ictus; Cerebrovascular Disease; Type2 Diabetes Mellitus; Microangiopathy

Study type: Observational

Funder types: Other

Identifiers

NCT02248311

PRECISED ISCiii-PIE-13

Details and patient eligibility

About

Current methods based on traditional Cardiovascular risk factors are not clinically useful for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in Type 2 Diabetes population have worse prognosis than in general population. In fact, there is sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects of ischemic events and worsens their outcome.

A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes patients. Therefore, new strategies aimed at identifying those patients with this subclinical Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a challenge to be met.

Full description

Objectives

1. To examine whether the extension and degree of microangiopathy is an independent risk factor for silent myocardial and brain ischemia. 2) To evaluate whether the degree and extension of microangiopathy is a predictor of CV events and poor outcome. 3) To evaluate whether a new score based on the extension and the degree of microangiopathy will permit us to improve the current methods used to identify patients at risk of CVD and its outcomes. 4) To determine whether the presence and the degree of NAFLD is an independent Cardiovascular disease risk factor and represent and extra-value to the score based on the extension and the degree of microangiopathy.

Secondary objectives:

1. To examine the usefulness of selected serum biomarkers in identifying diabetic patients at risk of Cardiovascular disease 2) To evaluate whether these selected biomarkers are related to the degree and extension of microangiopathy and the outcome of cardiovascular events. 3) To better define the meaning of microalbuminuria in type 2 diabetic population (glomerular involvement vs. index of generalized endothelial dysfunction)

Enrollment: 260 estimated patients

Sex: All

Ages: 50 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a) Age from 50-79 years; b) History of type 2diabetes of at least one year. Diabetes will be defined following the American Diabetic Association criteria: fasting glucose level of at least 126 mg/dl [7.0 mmol/l] in two separate analyses, a non-fasting glucose level of at least 200 mg/dl [11.1 mmol/l] or a self-reported history of physician-diagnosed diabetes or treatment for diabetes

Exclusion criteria

• a) Past medical history of Cardiovascular event; b) Type 1 diabetes; c) Contraindication for PET-CT or MRI d) Other concomitant disease associated with a short life expectancy

Trial design

260 participants in 2 patient groups

Patients/Control Group

Description:

Observational

Patients/Group Control

Description:

Observational