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

NCT03771209 | Unknown DMC

• 1 other identifier: ABCDE
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• discharge time shortening

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

  1 month

• ABCDE and events

  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)

  3 months

Secondary Outcomes (3)

• B lines and diuretics shifts

  1 month

• B lines and PaO2

  1 month

• B lines and natriuretic peptide

  1 month

Study Arms (1)

ultrasound assessment

EXPERIMENTAL

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.

Diagnostic Test: ultrasound examination

Interventions

ultrasound examination DIAGNOSTIC_TEST

ultrasound assessment

ultrasound assessment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• University of Palermo: collaborator
• University Of Perugia: collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator

Study Sites (1)

University of Verona

Verona, 37136, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 30172551 RESULT

MeSH Terms

Conditions

Heart Failure; Atherosclerosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• CHIARA MOZZINI, MD,PhD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• DOMENICO GIRELLI, MD,PhD

  Universita di Verona

  STUDY CHAIR

• MAURIZIO SORESI, MD,PhD

  University of Palermo

  STUDY CHAIR

Central Study Contacts

CHIARA MOZZINI, MD,PhD

CONTACT

+390458124262; chiara.mozzini@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 11, 2018
• Study Start: April 26, 2018
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

IT (1)