"ANTES" Proposal: A New Approach to Exacerbation in COPD Patients. Exacerbantes Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- To describe treatable traits (TTs) distribution in AECOPD
研究概览
简要总结
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is understood as a complex and heterogeneous syndrome, which requires an increasingly personalized approach. A new approach to AECOPD recognized that several etiopathogenic mechanisms can lead to a worsening ot the patients. This new approach is based on the identification of different treatable traits (TTs).
The goal of this observational study is to describe how TTs are distributed in patients with AECOPD in primary care (PC) and hospital emergencies department (HED) to address their complexity and heterogeneity.
As a secondary outcomes we also try to evaluate the relationship of TTs with relevant clinical outcomes (relapse, recurrence, MACE (Major Adverse Cardiovascular Event) and all-cause mortality) and create a risk score and compare this new severity score with Rome and GesEPOC proposals.
In the AP group, a series of basic tests for routine use will be systematically performed, among which chest x-ray, electrocardiogram and other new tests such as microspirometry (COPD-6) and a point of care determination of capillary C-reactive protein (CRP). In the HED group routine determinations will be expanded to include blood tests, arterial blood gases and biomarkers (CRP, TnT, NT-proBNP and D-Dimer). Patients will be re-evaluated 90 days after the initial episode, to evaluate different clinical outcomes. The estimated sample size is 400 patients.
详细描述
Justification COPD exacerbations (AECOPD) are heterogeneous and complex in nature, demanding an increasingly personalized approach. Recently, the ANTES proposal was presented, a patient-centered approach based on the treatable traits (TT) strategy. Other recent initiatives, such as the Rome proposal or GesEPOC, also propose new definitions and ways to classify the severity of AECOPD. However, none of these 3 new proposals have been validated.
Objectives:
- Main: Describe in a systematic way how the different TTs are distributed in patients with AECOPD in primary care (PC) and hospital emergencies department (HED).
- Secondary: (1) evaluate the relationship of the different treatable features with the following clinical outcomes: relapse, recurrence, MACE (Major Adverse Cardiovascular Event) and all-cause mortality; (2) create a risk scale for recurrence, readmission, MACE and/or mortality, both in PC and HED; (3) compare the predictive capacity of the risk scale generated from the ANTES proposal, with the Rome and GesEPOC severity scales; (4): in the subgroup of patients treated in the hospital, compare the 3 risk scales (ANTES, Roma and GesEPOC) with the valid DECAF scale (5); assess whether it is feasible to determine FEV1, through the use of microspirometers, during COPD decompensation; and (6) compare lung function evaluated during decompensation with that obtained after recovery, 90 days after the index event.
Material:
Prospective, multicenter, longitudinal, observational study on patients diagnosed with AECOPD in PC and HED. In the AP cohort, a series of basic tests for routine use will be systematically performed, among which chest x-ray, electrocardiogram and other new tests such as microspirometry (COPD-6) and determination of point of care capillary C-reactive protein (CRP). In the HED cohort, routine determinations will be expanded to include blood tests, arterial blood gases and biomarkers (CRP, TnT, NT-proBNP and D-Dimer). Patients will be re-evaluated 90 days after the initial episode, to evaluate different clinical outcomes (relapse, recurrence, MACE and mortality). The distribution of different TTs will be analyzed and a new predictive risk scale will be created from them, comparing it with the Rome and GesEPOC scales. The estimated sample size is 400 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women who request emergency care (primary care or hospital) due to acute worsening of respiratory symptoms (of any nature)
- •Age 40 years or older.
- •Smokers or ex-smokers of > 10 pack-years
- •Expiratory airflow limitation, documented by any of the following methods:
- •Post bronchodilation FEV1/FVC < 0.7, in a previous forced spirometry, or
- •FEV1/FEV6 less than 0.73 on microspirometry performed during decompensation
排除标准
- •Patients with active neoplasia in the last 3 years.
- •Associated pleural effusion susceptible to thoracentesis.
- •Pneumothorax.
- •Thoracic trauma.
- •Impossibility of subsequent follow-up (3 months).
结局指标
主要结局
To describe treatable traits (TTs) distribution in AECOPD
时间窗: Acute presentation of clinical worsening (less than 14 days)
A treatable trait is defined as a clinical, functional or biological features, which can be identified through the use of diagnostic tests or biomarkers, and which have a specific treatment
次要结局
- In the subgroup of patients seen in hospital, compare the 3 risk score proposals (ANTES, Roma and GesEPOC) with the DECAF score(90 days)
- To assess the feasibility of FEV1 measurement by using a micro spirometer during COPD decompensation(During the first attendance of AECOPD (hours))
- To explore the creation of a predictive risk score (recurrence/ readmission/mortality/MACE) based on the patient-focused approach from the ANTES proposal in both PC and hospital emergency settings.(90 days)
- 6. To compare the lung function evaluated during COPD decompensation with that obtained after recovery, 90 days after the index event(90 days)
- To evaluate the relationship of the different RTs with the following outcomes: relapse, recurrence, major adverse cardiovascular event (MACE) and mortality(90 days of follow-up)
- To compare the predictive capacity of the risk score generated from the ANTES proposal, with the Rome and GesEPOC severity scores(90 days)
研究者
Juan José Soler Cataluna, MD
Pneumologist
Sociedad Española de Neumología y Cirugía Torácica