The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure
Primary Purpose
Heart Failure, Atherosclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ultrasound examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring ultrasound assessment, ankle brachial index, lung ultrasound, carotid intima media thickness, vascular ultrasound (abdominal aorta and cave vein), echocardiographic ejection fraction
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
Sites / Locations
- University of VeronaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ultrasound assessment
Arm Description
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.
Outcomes
Primary Outcome Measures
discharge time shortening
B-lines number in relation to the discharge time (number of days of hospitalization)
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)
Secondary Outcome Measures
B lines and diuretics shifts
association between B lines number and the number of diuretics shifts during hospitalization and recovery from HF
B lines and PaO2
association 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 peptide
the association of B lines number and natriuretic peptide blood levels (ng/mL)
Full Information
NCT ID
NCT03771209
First Posted
December 5, 2018
Last Updated
December 10, 2018
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborators
University of Palermo, University Of Perugia, IRCCS Sacro Cuore Don Calabria di Negrar
1. Study Identification
Unique Protocol Identification Number
NCT03771209
Brief Title
The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure
Official Title
The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure:a Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
April 26, 2022 (Anticipated)
Study Completion Date
April 26, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborators
University of Palermo, University Of Perugia, IRCCS Sacro Cuore Don Calabria di Negrar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ultrasound assessment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound examination
Intervention Description
ultrasound assessment
Primary Outcome Measure Information:
Title
discharge time shortening
Description
B-lines number in relation to the discharge time (number of days of hospitalization)
Time Frame
1 month
Title
ABCDE and events
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
B lines and diuretics shifts
Description
association between B lines number and the number of diuretics shifts during hospitalization and recovery from HF
Time Frame
1 month
Title
B lines and PaO2
Description
association between B lines number and calculated ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) at admission and discharge
Time Frame
1 month
Title
B lines and natriuretic peptide
Description
the association of B lines number and natriuretic peptide blood levels (ng/mL)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHIARA MOZZINI, MD,PhD
Phone
+390458124262
Email
chiara.mozzini@univr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHIARA MOZZINI, MD,PhD
Organizational Affiliation
Universita di Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DOMENICO GIRELLI, MD,PhD
Organizational Affiliation
Universita di Verona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MAURIZIO SORESI, MD,PhD
Organizational Affiliation
University of Palermo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Verona
City
Verona
ZIP/Postal Code
37136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIARA MOZZINI, MD,PhD
Phone
+390458124262
Email
chiara.mozzini@univr.it
First Name & Middle Initial & Last Name & Degree
chiara mozzini, MD,PhD
First Name & Middle Initial & Last Name & Degree
maurizio soresi, MD
First Name & Middle Initial & Last Name & Degree
domenico girelli, MD,PhD
First Name & Middle Initial & Last Name & Degree
marco di dio perna, MD
First Name & Middle Initial & Last Name & Degree
stefano ministrini, MD
First Name & Middle Initial & Last Name & Degree
francesco fantin, MD
First Name & Middle Initial & Last Name & Degree
luciano cominacini, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30172551
Citation
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.
Results Reference
result
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The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure
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