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

NCT02248311 | Unknown

• 1 other identifier: PRECISED ISCiii-PIE-13
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ischemic events

  3 years

Study Arms (2)

Patients/Control Group

Observational

Patients/Group Control

Observational

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitario Valle de Hebron

Barcelona, 08035, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients: 200 Control group: 60

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Coronary Artery Disease; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

ES (1)