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

NCT ID: NCT03771209

Last Updated: 2018-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2022-04-26

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.

Conditions

Heart Failure; Atherosclerosis

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ultrasound assessment

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.

Group Type: EXPERIMENTAL

ultrasound examination

Intervention Type: DIAGNOSTIC_TEST

ultrasound assessment

Interventions

ultrasound examination

ultrasound assessment

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Palermo

OTHER

Sponsor Role: collaborator

University Of Perugia

OTHER

Sponsor Role: collaborator

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Chiara Mozzini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CHIARA MOZZINI, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

DOMENICO GIRELLI, MD,PhD

Role: STUDY_CHAIR

Universita di Verona

MAURIZIO SORESI, MD,PhD

Role: STUDY_CHAIR

University of Palermo

Locations

University of Verona

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

CHIARA MOZZINI, MD,PhD

Role: CONTACT

Phone: +390458124262

Email: chiara.mozzini@univr.it

Facility Contacts

CHIARA MOZZINI, MD,PhD

Role: primary

References

Mozzini C, Cominacini L, Casadei A, Schiavone C, Soresi M. Ultrasonography in Heart Failure: A Story that Matters. Curr Probl Cardiol. 2019 Apr;44(4):116-136. doi: 10.1016/j.cpcardiol.2018.05.003. Epub 2018 Jun 21.

Reference Type: RESULT

PMID: 30172551 (View on PubMed)

Other Identifiers

ABCDE

Identifier Type: -

Identifier Source: org_study_id