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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248311
Recruitment Status : Unknown
Verified January 2018 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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
Type2 Diabetes Mellitus Microangiopathy Non Alcoholic Fatty Liver Disease Coronary Artery Disease Cerebrovascular Disease 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)

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Study Type : Observational
Estimated 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 : September 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : October 2018


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



Primary Outcome Measures :
  1. Subclinical Cardiovascular Diseases [ Time Frame: 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 :
  1. Ischemic events [ Time Frame: 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)


Biospecimen Retention:   Samples Without DNA
Patients: 200 Control group: 60


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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248311


Locations
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Spain
Hospital Universitario Valle de Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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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

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02248311    
Other Study ID Numbers: PRECISED ISCiii-PIE-13
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Cerebrovascular Disorders
Coronary Artery Disease
Myocardial Infarction
Acute Coronary Syndrome
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases