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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03771209
Enrollment
480
Registered
2018-12-11
Start date
2018-04-26
Completion date
2022-04-26
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Heart Failure

Keywords

ultrasound assessment, ankle brachial index, lung ultrasound, carotid intima media thickness, vascular ultrasound (abdominal aorta and cave vein), echocardiographic ejection fraction

Brief summary

Heart failure (HF) is a clinical syndrome caused by structural and/or functional cardiac abnormalities, resulting in a reduced cardiac output and/or elevated intra-cardiac pressures at rest or during stress. It is the leading cause of hospitalization in Internal Medicine departments. This study aims at exploring evidence of the importance of ultrasound in HF both for hospitalized patients and in the follow up. Ultrasound may be used as a recovery monitoring instrument at the bedside and also as a global cardiovascular assessment tool for these patients. HF represents an exciting opportunity to create an integrative ultrasound approach in Internal Medicine/Geriatric departments.The Authors plan a five-step ultrasound examination to evaluate and monitor HF patients during hospitalization and follow-up. They call this examination: the ABCDE score. It includes the evaluations of A, the Ankle-brachial index (ABI), B, the B-lines, C, the Carotid intima media thickness (CIMT), D, the Diameter of the abdominal aorta and of the inferior cave vein and E, the echocardiographic assessment of the ejection fraction.This score represent an integrative ultrasound approach in Internal Medicine/Geriatric departments.

Detailed description

Background: Heart failure (HF) is a clinical syndrome characterized by typical symptoms and signs caused by structural and/or functional cardiac abnormalities, resulting in a reduced cardiac output and/or elevated intra-cardiac pressures at rest or during stress. The prevalence of HF is approximately 1-2% of the adult population in developed countries, rising to ≥10% among people \>70 years of age and it is the leading cause of hospitalization. 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. The ABCDE score includes the evaluations of A, the Ankle-brachial index, ABI, B, the B-lines, C, the Carotid intima media thickness, CIMT, D, the Diameter of the abdominal aorta and of the inferior cave vein and E, the echocardiographic assessment of the ejection fraction. This score represents an integrative ultrasound approach in the Internal Medicine/Geriatric departments: A (ANKLE-BRACHIAL INDEX) Normal (\<90): points 0 Mild obstruction (0.71-0.90): points 1 Moderate obstruction (0.41-0.70): points 2 Severe obstruction 0-0.40): points 3 B (B-LINES) Number of B-lines for each space ≤5: points 0 Number of B-lines for each space ≥ 6 to ≤ 9: points 1 Number of B-lines for each space ≥ 10 (Full white screen): points 3 C (IMT OR CAROTID PLAQUE) Normal: points 0 Altered IMT (\>0.9 mm): points 1 Plaque presence (no significant stenosis, \<70% following NASCET classification): points 2 Plaque presence (significant stenosis, \>70% following NASCET classification): points 3 D (DIAMETER OF AORTA AND VCI COLLAPSIBILITY INDEX) Aorta Normal (\<25 mm): points 0 Normal diameter but with calcifications: points 1 Ectasia (25-30 mm): points 2 Aneurysm (\>30mm): points 3 Cave Vein Normal collapsibility index (40-75%): points 0 Altered collapsibility index (if \<40% or \>75%): points 1 E (EF ACCORDING TO ESC GUIDELINES 2016) HFpEF (LVEF ≥50%): points 0 HFmrEF (LVEF in the range of 40-49%):points 1 HFrEF (LVEF\<40%): points 2 Methods: The study population is composed of a consecutive sample of n' HF patients admitted from the Emergency to the Internal Medicine (IM)/Geriatric Departments of n' University Hospitals from Italy or other foreign countries. HF criteria will be established according to the recent ESC 2016 guidelines. In particular, patients will be classified in three different classes: with normal left ventricular ejection fraction (LVEF) ( ≥50%, HF with preserved EF, HFpEF), with reduced LVEF ( \<40%, HF with reduced EF, HfrEF) and with an LVEF in the range of 40-49% (HfmrEF). Moreover, patients are classified according to New York Heart Association (NYHA) classes at admission, at discharge and during follow-up. Exclusion criteria are: concomitant acute coronary syndrome, pneumonia, chronic obstructive pulmonary disease, lung cancer or metastases, lung fibrosis, previous pneumonectomy or lobectomy, breast prothesis, obesity, also in order to to avoid the detection of B-lines other than due to HF. Patients undergo: A (calculated for each leg at admission), B-lines counting (calculated at admission, during hospital stay and at discharge with lung ultrasound, approach 72 spaces), C (at admission), D (at admission for the aorta and at admission, during hospital stay and at discharge for the inferior cave vein) and E (at admission and discharge). Venous blood samples are collected from each subject for routine examination on admission: hemoglobin and white blood cells count, serum creatinine, sodium, potassium, urea, total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides, glucose, C-reactive protein (CRP) (measured with standard methods). Moreover, NT-proBNP dosage is obtained on admission and on discharge. Urine output and diuretic dosage will be carefully reported daily. Arterial blood samples is collected on admission and on discharge to test the partial pressure of oxygen (PaO2) as indicator of HF severity (on admission) and recovery (on discharge). An electrocardiogram recording and X-chest ray examination are obtained on admission. MEDICAL STAFF INVOLVED IN THE ULTRASOUND EXAMINATIONS A is performed by the IM/Geriatric specialists or certification board attending students. B,C and D examinations are performed by Medical Doctors (Radiologists or IM/Geriatric specialists certified by the Società Italiana di Ultrasonologia in Medicina e Biologia (SIUMB). Trans-thoracic echocardiography with estimation of E is performed by Cardiologists or IM specialists certified by the Società Italiana di Ecografia Cardiovascolare, SIEC. * ENDPOINTS: 1\) RELATED TO THE BEDSIDE EVALUATION OF HF RECOVERY: * test if B,D (for cave vein) and E assessment can precisely guide and tailoring the therapy (diuretics) during hospitalization and recovery from HF; * test if B,D (for cave vein) and E assessment can speed up the discharge time (if compared to patients without ultrasound assessment); * improve the use of bedside ultrasound in IM and Geriatric department. 2) RELATED TO THE GLOBAL CARDIOVASCULAR ASSESSMENT OF THE HF PATIENT: * test if A, C and D (for aorta) assessment can better classify the global cardiovascular risk for the HF patient. The severity of the score will be related with: * number of hospitalization days * number of events during follow up (for definition of events, see follow up section). FOLLOW-UP Follow-up is performed by contacting patients or their caregivers over the phone 30 and 90 days after the date of discharge. All the successive re-admissions for HF or deaths from any cause are considered as events. A potential correlation between the severity of each parameter considered in the ABCDE score with the events after discharge is tested.

Interventions

DIAGNOSTIC_TESTultrasound examination

ultrasound assessment

Sponsors

University of Palermo
CollaboratorOTHER
University Of Perugia
CollaboratorOTHER
IRCCS Sacro Cuore Don Calabria di Negrar
CollaboratorOTHER
Azienda Ospedaliera Universitaria Integrata Verona
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* HF patients admitted from the Emergency to the Internal Medicine (IM)/Geriatric Departments

Exclusion criteria

* concomitant acute coronary syndrome * pneumonia * chronic obstructive pulmonary disease * lung cancer or metastases * lung fibrosis * previous pneumonectomy or lobectomy * breast prothesis * obesity

Design outcomes

Primary

MeasureTime frameDescription
discharge time shortening1 monthB-lines number in relation to the discharge time (number of days of hospitalization)
ABCDE and events3 monthsassociation 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)

Secondary

MeasureTime frameDescription
B lines and diuretics shifts1 monthassociation between B lines number and the number of diuretics shifts during hospitalization and recovery from HF
B lines and PaO21 monthassociation between B lines number and calculated ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) at admission and discharge
B lines and natriuretic peptide1 monththe association of B lines number and natriuretic peptide blood levels (ng/mL)

Countries

Italy

Contacts

Primary ContactCHIARA MOZZINI, MD,PhD
chiara.mozzini@univr.it+390458124262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026