Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-11-19
Brief Title:
Exacerbantes Study
Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Organization:
Sociedad Española de Neumología y Cirugía Torácica
Study Overview
Official Title:
ANTES Proposal A New Approach to Exacerbation in COPD Patients Exacerbantes Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None