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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT02248311

Collaborator

(none)

260

Enrollment

Location

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Mellitus Microangiopathy Non Alcoholic Fatty Liver Disease Coronary Artery Disease Cerebrovascular Disease Acute Coronary Syndrome/ Myocardial Infarction Ictus

Detailed Description

Objectives

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:

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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

260 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients/Control Group Observational
Patients/Group Control Observational

Outcome Measures

Primary Outcome Measures

Subclinical Cardiovascular Diseases [1 week]
Number of Type 2 Diabetes (T2D) patients presenting subclinical Cardiovascular disease as defined by the presence of brain infarcts (MRI), myocardial infarcts, or myocardial ischemia or > 50% coronary artery stenosis (PET-SPECT)

Secondary Outcome Measures

Ischemic events [3 years]
Occurrence of Cardiovascular events during the 3 year follow up: Ictus, transient ischemic attack, acute coronary syndrome (STEMI or NSTEMI), angina, sudden cardiac death. Incidence of major adverse cardiovascular events at 30 days following acute ischemic syndrome (Death, Re-infarction, Ictus)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. 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:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Valle de Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

Principal Investigator: David García-Dorado Garcia, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain
Principal Investigator: Joan Montaner Vilallonga, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain
Principal Investigator: Rafael Simó Canonge, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain
Principal Investigator: Joan Sayós Ortega, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain
Principal Investigator: Daniel Serón Micas, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain
Principal Investigator: Joan Genescà Ferrer, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain
Principal Investigator: Santiago Aguadé Bruix, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain
Principal Investigator: Joan Xavier Comella Carnicé, PhD MD, Hospital Universitario Valle de Hebron, Barcelona, Spain