"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population (PRECISED)
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|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
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|
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.
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|
|Estimated Enrollment :||260 participants|
|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|
- 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)
- 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
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
|Hospital Universitario Valle de Hebron|
|Barcelona, Spain, 08035|
|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|