Clinical trial NCT02248311: "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population
Official title: "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population: a Multidisciplinary Clinical and Experimental Approach" (PRECISED)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2 Diabetes Mellitus
Microangiopathy
Non Alcoholic Fatty Liver Disease
Coronary Artery Disease
Cerebrovascular Disease
Acute Coronary Syndrome/ Myocardial Infarction
Ictus
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 260
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 200 T2D diabetic patients without history of clinical Cardiovascular disease will be recruited from the Outpatient Diabetic Clinic of Vall d'Hebron Hospital and the Primary Health Care centers under its influence area. Sixty non-diabetic patients without classic Cardiovascular risk factors matched by age will be used as a control group. Specifically, vascular risk factors, concomitant diseases, family history of Cardiovascular disease or stroke and the treatments taken at the time of inclusion will be collected.

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Subclinical Cardiovascular Diseases
timeFrame: 1 week
Secondary outcomes:
measure: Ischemic events
timeFrame: 3 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitario Valle de Hebron
Study officials:
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: David García-Dorado Garcia, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: Joan Montaner Vilallonga, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: Rafael Simó Canonge, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: Joan Sayós Ortega, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: Daniel Serón Micas, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: Joan Genescà Ferrer, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: Santiago Aguadé Bruix, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Valle de Hebron, Barcelona, Spain
name: Joan Xavier Comella Carnicé, PhD MD
role: PRINCIPAL_INVESTIGATOR
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