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临床试验/NCT03771209
NCT03771209Unknown不适用

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

Azienda Ospedaliera Universitaria Integrata Verona2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2018年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
480
试验地点
2
主要终点
ABCDE and events

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: ultrasound examination (Diagnostic Test)

结局指标

主要结局

ABCDE and events

时间窗: 3 months

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)

discharge time shortening

时间窗: 1 month

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

次要结局

  • B lines and diuretics shifts(1 month)
  • B lines and natriuretic peptide(1 month)
  • B lines and PaO2(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiara Mozzini

Principal Investigator

Azienda Ospedaliera Universitaria Integrata Verona

研究点 (2)

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