NCT02248311

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

"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population: a Multidisciplinary Clinical and Experimental Approach" (PRECISED)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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)

Conditions

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

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-02-01
• Completion: 2018-10-01
• First posted: 2014-09-25
• Last updated: 2018-01-23

Locations

1 site across 1 country: Spain