- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248311
"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
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08035
- Hospital Universitario Valle de Hebrón
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients/Control Group
Observational
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Patients/Group Control
Observational
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subclinical Cardiovascular Diseases
Time Frame: 1 week
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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)
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1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ischemic events
Time Frame: 3 years
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3 years
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Collaborators and Investigators
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
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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