The aim of this study is the creation of a five-step ultrasound examination to evaluate and monitor HF patients during hospitalization and short follow-up.

Heart Failure

Atherosclerosis

ultrasound examination

University of Verona

The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure

The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure:a Multi-center Study

B-lines number in relation to the discharge time (number of days of hospitalization)

association between number of altered ultrasound parameters and number of "events" (death from any cause or re-admission for HF) in a follow up period (30 and 90 days from discharge)

association between B lines number and the number of diuretics shifts during hospitalization and recovery from HF

association between B lines number and calculated ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) at admission and discharge

the association of B lines number and natriuretic peptide blood levels (ng/mL)

Chiara Mozzini

Principal Investigator

Azienda Ospedaliera Universitaria Integrata Verona

University of Palermo

University Of Perugia

IRCCS Sacro Cuore Don Calabria di Negrar

In the Mobile Unit (MU), clinical, sociodemographic and anthropometric data will be recorded. Patients will be evaluated with artery ultrasound (carotid, femoral, transcranial and abdominal aorta), ankle-brachial index, pulse wave velocity, spirometry, determination of advanced glycation-end products, atrial fibrillation screening, dried blood spot test and urine analysis. Moreover, DNA, RNA, Saliva, blood and urine samples will be collected and stored in the biobank to identify new biomarkers using omic studies. Additionally, climate, air pollutant and airborne pollen data form the entire province of Lleida will be registered. Finally, a report with the exploration results and recommendations based on the current guidelines will be uploaded to the e-CAP history for the Primary care evaluation.

Participants will be followed through their electronic medical records. Sociodemographic (age, sex, race, marital status, education and labour status), clinical and anthropometric data and will be electronically collected.

Chronic Kidney Diseases

Metabolic Syndrome

PreDiabetes

Subclinical Disease and/or Syndrome

Dried capillary blood testing creatinine, uric acid and total cholesterol (reflotron® Plus system, Roche). Determination of the complete lipid profile in cases in which total cholesterol is greater than 200 mg/dl: HDL cholesterol (mg/dl), LDL cholesterol (mg/dl) and triglycerides (mg/dl) (Cobas B 101® system, Roche). Calculation of non-HDL cholesterol levels. Glycated haemoglobin will be analysed with the Cobas B 101 system,Roche. The CKD-EPI glomerular filtration rate will be determined.

Dried blood spot test

A urine sample from spontaneous micturition will be collected and analyzed using Clinitek Microalbumin 2 Reagent Strips and a Siemens Clinitek Status® analyzer. It will be determined albuminuria (mg/l) and albumin/creatinine ratio (mg/g).

Urine test

Carotid and femoral artery ultrasound for atheroma plaque diagnosis. Abdominal aorta ultrasound for early diagnosis of aortic aneurism. Transcranial ultrasound for cerebral arterial blood flow alterations.

Artery ultrasound

Systolic blood pressure measurement in the brachial artery, posterior tibial artery and dorsalis pedis artery in both limbs. The ratios between tibial and pedal systolic blood pressure in each leg and the higher brachial blood pressure will be calculated.

Ankle-brachial index

Spirometry will be used to assess lung capacity. It will be performed by the same nurse who will measure forced vital capacity (FVC); forced expiratory volume in one second (FEV1); the ratio between FEV1 and FVC and the lower limit of normality, as a percentage.

Spirometry

These will be measured using skin autofluorescence (SAF) in the forearm with the AGE Reader® system (Diagnostics, the Netherlands). SAF is measured using spectrophotometry which is calculated as the relationship of the intensity of reflected light compared to refracted light.

Determination of advanced glycation-end products

The presence of atrial fibrillation is assessed with a device (SRA, EVINA Health Solutions) during one hour in the mobile unit.

Atrial fibrillation screening

Blood samples from a peripheral vein of the hand or forearm to obtain serum, plasma, DNA and RNA will be collected. Moreover, a saliva sample will be collected.These samples will be prepared in aliquots following a standardized protocol, and sent frozen (dry ice) to a centralized biobank (IRBLleida Biobank, Spain) for processing and storage for subsequent studies of CV, inflammatory and mineral-metabolism biomarkers and genetic polymorphisms. Urine samples will be frozen and stored in a biobank for subsequent study of biomarkers.

Biological sample collection

A report with exploration results and recommendations based on the current guidelines will be uploaded to the e-CAP history for the Primary care evaluation.

Result and recommendation report

Pulse wave velocity (PWV) will be used as an indicator of arterial stiffness. It will be measured non-invasively with the carotid to femoral PWV (cfPWV) according to standard protocols.

Pulse wave velocity

Fundació Renal Jaume Arnò

Primary Care centre

Institut de recerca Biomèdica de Lleida

The ILERVAS Project: Assessing the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease

Randomized Intervention Study to Assess the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease and Its Impact on Morbidity and Mortality: The ILERVAS Project

The presence of atherosclerosis will be identified as an intima-media thickness higher than 1.5 mm.

The percentage of glycated hemoglobin (Hb A1c) will be determined with a Cobas b 101® machine (Roche). Values lower than 5.7% are normal, > 5.7-6.5% indicate pre-diabetes; and ≥ 6.5% indicate diabetes.

The prevalence of hidden chronic kidney disease will be assessed with a urine spot test that determines the albumin/creatinine ratio (ACR). Values lower than 30 mg/g are normal; 30-300 mg/g indicate microalbuminuria; and values higher than 300 indicate macroalbuminuria.

The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10). Cardiovascular events and mortality in the intervention group will be compared to the control group during a during a 10-year follow-up period.

The percentage of glycated hemoglobin (Hb A1c) will be determined with a Cobas b 101® machine (Roche). Values lower than 5.7% are normal; 5.7-6.5% indicate pre-diabetes; and ≥ 6.5% indicate diabetes.

Skin autofluorescence will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values range from 1-24 units.

Adherence to the Mediterranean diet will be evaluated with the Mediterranean Diet Adherence screener (MEDAS). Values are from 0 to 14 and categorize subjects according to their level of adherence: high (score >11 points), moderate (7-10 points), and low (<6 points).

Physical exercise will be evaluated with the International Physical Activity Questionnaire (IPAQ). Values are from vigorous, moderate, and low physical activity. Low activity corresponds to no activity or some activity but not enough to meet moderate category. Moderate corresponds to 3 or more days of walking for at least 30 minutes. Vigorous activity corresponds to 5 or more days of walking for at least 60 minutes.

The presence of atrial fibrillation is assessed with stroke risk analysis device (SRA, EVINA Health Solutions).

Forced vital capacity (FVC) will be measured as liters (l).

AGES will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values range from 1-24 units.

Physical exercise will be evaluated with the International Physical Activity Questionnaire (IPAQ). Values are from vigorous, moderate, and low physical activity.

Elvira Fernández Giráldez

Study Chair

Institut de Recerca Biomèdica de Lleida

Diputació de Lleida

Jaume Arnó Renal Foundation

Unit of Detection and Treatment of Atherothrombotic diseases (UDETMA)

Lleida Primary health care

A randomized interventional study with 2 arms that will include 16,660 individuals with at least one cardiovascular risk factor from the province of Lleida, Spain. Patients will be recruited from January 2015 to December 2018. Patients will be followed for 10 years.

Patients on atorvastatin treatment hospitalised due to cardiovascular events

Cardiovascular Disorders

Patients on atorvastatin treatment

Rio University Hospital

Euroclinic Private Hospital

Evagelismos General State Hospital

Gennimatas General State Hospital

Konstantopoulio General Hospital

General State Hospital

University Hospital

Hippokration General Hospital

Sismanogleio General State Hospital

Tzannion General State Hospital

424 Military Hospital

Papageorgiou Hospital

Ekvasis of Atorvastatin (Antorcin®) Treatment in Patients With Acute Cardiovascular Events

A Multicenter, Open-label, 30-week Observational Clinical Study to Examine the Progress of Patients After Leaving the Cardiology Clinic or Unit Due to Acute Cardiovascular Event.

The evaluation of atorvastatin treatment to all patients with cardiovascular events and separate the two subgroups (diabetes type II patients with metabolic syndrome) in order to achieve the level of lipids (LDL-C, HDL-C, T-CHOL) plasma blood

Achieving the level of lipids (LDL-C, HDL-C, T-CHOL) in blood plasma of patients in the atorvastatin dosage: those who received the 40 mg dose and those who received a dose of 80 mg

The investigation of compliance to treatment (days without taking medication, changing the time of intake) and its correlation with the achievement of target lipid levels (LDL-C, HDL-C, T-CHOL) in blood plasma of the studied patients

Safety evaluation by adverse events reporting

The reporting of hematological and biochemical tests where conducted at each hospital center, as part of their standard clinical practice

The determination of dyslipidemia class it belongs to each patient in order to assess the efficacy of atorvastatin administered.

aneurysm/triglyceride

The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure

The ILERVAS Project: Assessing the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease

Ekvasis of Atorvastatin (Antorcin®) Treatment in Patients With Acute Cardiovascular Events

Cardiac and Skeletal Muscle Energy Metabolism in Abnormal Growth Hormone States

Honolulu Heart Program

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