Ignite Creation Date:
2024-05-06 @ 3:36 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02324660
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2014-12-18
Brief Title:
Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
Prospective Evaluation of a Screening Methodology for Chronic Obstructive Pulmonary Disease in Patients Admitted to Hospital for Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2017-05
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:
SCAP
Brief Summary:
Several studies and registries suggested that the concomitant presence of acute coronary syndromes ACS and chronic obstructive pulmonary disease COPD is significantly associated with poor prognosis It has been suggested that diagnosis of COPD is frequently missing Thus it is plausible that a significant percentage of patients with ACS may have unrecognized COPD This missing diagnosis may contribute significantly to poor prognosis The investigators suppose that the concomitant use of peak expiratory flow PEF measurement and of Respiratory Health Screening Questionnaire RHSQ adapted version could be useful as screening test for COPD in patient smokers or former smokers admitted to hospital with a diagnosis of ACS In all screened patients COPD diagnosis will be confirmed or not two months after hospital discharge with spirometry In the same setting of patients the investigators will characterize the underlying pathological mechanisms evaluating several inflammation platelet and endothelial markers
Detailed Description:
BACKGROUND
Acute coronary syndromes ACS and chronic obstructive pulmonary disease COPD are respectively the first and the fourth leading cause of death in Western countries ACS and COPD shared several risk factor in particular smoking habitus Available data may be summarized as follows i ACS and generally ischemic heart disease IHD are the most frequent comorbidity in COPD patients ii cardiac adverse events are the most frequent cause of hospitalization andor death in COPD patients iii patients with ACS and concomitant COPD are at higher risk of mortality re-infarction and heart failure HF iv COPD is frequently undiagnosed in patients with IHD At the best of our knowledge no studies investigated the effectiveness and feasibility of screening procedures to early detect COPD in ACS patients The identification of unrecognized COPD in ACS patients may permit an optimization of the treatment with an significant improvement in the outcome Finally it is well known that several biological processes are involved in the development and worsening of IHD-COPD comorbidity eg inflammation hypoxia heightened platelet reactivity endothelial dysfunction Nevertheless a complete evaluation of these processes is currently missing A better characterization of these biological processes underlying the ACS-COPD comorbidity may significantly improve its management
HYPOTHESIS and SIGNIFICANCE
Based on previous studies in patients with stable IHD we suppose that at least 30 of patients admitted to hospital for ACS have undiagnosed COPD They represent a subgroup of patients at very high risk of death reinfarction and heart failure We hypothesize that the combined use of PEF and RHSQ adapted version in ACS patients smokers or former smokers before hospital discharge may discriminate those with undiagnosed COPD The early diagnosis of COPD comorbidity may have important clinical implications We speculate that early identification of undiagnosed COPD in ACS patients may permit a promptly treatment and improve outcomes Finally we suppose that the worst outcome observed in ACS patients with undiagnosed COPD as well as in patients with prior ACS and acute exacerbation of COPD is due to a specific pattern of alterations in platelet reactivity PR endothelial function EF and inflammation Therefore their characterization may lead to an improvement in the clinical management of these patients
METHODS
Blood samples At the time of enrollment an aliquot 7-10 ml of whole blood will be collected and stored for DNA and RNA extraction Blood samples to obtain plasma 7-10 ml and serum 7-10 ml will be collected both at the timing of enrolment and at the time of spirometry
Screening procedure PEF and RHSQ adapted version will be administered by an independent combined team of cardiologist and pulmonologist before the hospital discharge According to international guidelines patients will be asked to perform 3 consecutive PEF measurements and the highest values will be recorded A PEF value below 80 predicted will be considered predictive of impaired lung function The RHSQ questionnaire will be performed as previously reported with a value 19 suggesting high probability of COPD
Spirometry spirometry test will be performed 50-70 days after hospital discharge enrollment time
Primary outcome of the study the endpoint of the study is the diagnosis of COPD at spirometry The aim of the study is to establish if the combined use of PEF and RHSQ questionnaire is able to early predict COPD diagnosis
Clinical follow-up a complete 1-year follow-up will be collected in each patient recording the occurrence of all adverse events and hospital admissions All adverse events will be adjudicated by two independent reviewers blinded to screening and spirometry outcomes
Biological parameters several evaluations of inflammation endothelial and platelet function markers will be performed in blood samples from patients The principals are reported below high sensitivity C-reactive protein fibrinogen interleukin IL-6 IL-1Ra tumor necrosis factor TNF-alpha platelet reactivity as assessed by light transmission aggregometry and VerifyNow system ICAM and Bcl-2 and e-NOS extracellular nitric oxide synthase in human umbilical vein endothelial cells that will be incubate with serum of patients intracellular levels of reactive oxygen species
Secondary outcomes PEF RHSQ biological parameters and spirometry results will be related to clinical outcome
Acute coronary syndromes ACS and chronic obstructive pulmonary disease COPD are respectively the first and the fourth leading cause of death in Western countries ACS and COPD shared several risk factor in particular smoking habitus Available data may be summarized as follows i ACS and generally ischemic heart disease IHD are the most frequent comorbidity in COPD patients ii cardiac adverse events are the most frequent cause of hospitalization andor death in COPD patients iii patients with ACS and concomitant COPD are at higher risk of mortality re-infarction and heart failure HF iv COPD is frequently undiagnosed in patients with IHD At the best of our knowledge no studies investigated the effectiveness and feasibility of screening procedures to early detect COPD in ACS patients The identification of unrecognized COPD in ACS patients may permit an optimization of the treatment with an significant improvement in the outcome Finally it is well known that several biological processes are involved in the development and worsening of IHD-COPD comorbidity eg inflammation hypoxia heightened platelet reactivity endothelial dysfunction Nevertheless a complete evaluation of these processes is currently missing A better characterization of these biological processes underlying the ACS-COPD comorbidity may significantly improve its management
HYPOTHESIS and SIGNIFICANCE
Based on previous studies in patients with stable IHD we suppose that at least 30 of patients admitted to hospital for ACS have undiagnosed COPD They represent a subgroup of patients at very high risk of death reinfarction and heart failure We hypothesize that the combined use of PEF and RHSQ adapted version in ACS patients smokers or former smokers before hospital discharge may discriminate those with undiagnosed COPD The early diagnosis of COPD comorbidity may have important clinical implications We speculate that early identification of undiagnosed COPD in ACS patients may permit a promptly treatment and improve outcomes Finally we suppose that the worst outcome observed in ACS patients with undiagnosed COPD as well as in patients with prior ACS and acute exacerbation of COPD is due to a specific pattern of alterations in platelet reactivity PR endothelial function EF and inflammation Therefore their characterization may lead to an improvement in the clinical management of these patients
METHODS
Blood samples At the time of enrollment an aliquot 7-10 ml of whole blood will be collected and stored for DNA and RNA extraction Blood samples to obtain plasma 7-10 ml and serum 7-10 ml will be collected both at the timing of enrolment and at the time of spirometry
Screening procedure PEF and RHSQ adapted version will be administered by an independent combined team of cardiologist and pulmonologist before the hospital discharge According to international guidelines patients will be asked to perform 3 consecutive PEF measurements and the highest values will be recorded A PEF value below 80 predicted will be considered predictive of impaired lung function The RHSQ questionnaire will be performed as previously reported with a value 19 suggesting high probability of COPD
Spirometry spirometry test will be performed 50-70 days after hospital discharge enrollment time
Primary outcome of the study the endpoint of the study is the diagnosis of COPD at spirometry The aim of the study is to establish if the combined use of PEF and RHSQ questionnaire is able to early predict COPD diagnosis
Clinical follow-up a complete 1-year follow-up will be collected in each patient recording the occurrence of all adverse events and hospital admissions All adverse events will be adjudicated by two independent reviewers blinded to screening and spirometry outcomes
Biological parameters several evaluations of inflammation endothelial and platelet function markers will be performed in blood samples from patients The principals are reported below high sensitivity C-reactive protein fibrinogen interleukin IL-6 IL-1Ra tumor necrosis factor TNF-alpha platelet reactivity as assessed by light transmission aggregometry and VerifyNow system ICAM and Bcl-2 and e-NOS extracellular nitric oxide synthase in human umbilical vein endothelial cells that will be incubate with serum of patients intracellular levels of reactive oxygen species
Secondary outcomes PEF RHSQ biological parameters and spirometry results will be related to clinical outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None