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

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

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.

Study Overview

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

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)

• Study Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Valle de Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients/Control Group; Observational
Patients/Group Control; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subclinical Cardiovascular Diseases	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)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic events	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)	3 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 20, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Coronary Disease; Liver Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease; Acute Coronary Syndrome; Cerebrovascular Disorders
• Other Study ID Numbers: PRECISED ISCiii-PIE-13