- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02324660
Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes (SCAP)
Prospective Evaluation of a Screening Methodology for Chronic Obstructive Pulmonary Disease in Patients Admitted to Hospital for Acute Coronary Syndromes.
Study Overview
Status
Intervention / Treatment
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 and/or 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 (e.g. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ferrara
-
Cona, Ferrara, Italy, 44124
- University Hospital of Ferrara
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age >40 years
- typical chest pain during at least 20 minutes
- ST-segment changes on electrocardiography, indicating ischemia and/or positive test of a biomarker (troponin and/or CK-MB), indicating myocardial necrosis
- current or former history of smoking
Exclusion Criteria:
- previous diagnosis of COPD and/or asthma
- known pulmonary disease
- ongoing pneumonia
- ongoing heart failure
- documented or suspicion of malignant disease
- life expectancy <1 year
- recent thoracic trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: screening test
all consecutive patients admitted to our hospital for ACS and current/former smokers will be screened according our protocol with PEF and RHSQ.
Patients will be blinded to result of both tests.
Indipendently to results, all included patients will receive spirometry (50-70 days after inclusion) to assess the presence or not of COPD (primary outcome).
|
screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COPD Diagnosis
Time Frame: 2 months after inclusion
|
COPD diagnosis confirmed by spirometry
|
2 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Adverse Events
Time Frame: 1 year after inclusion
|
cumulative occurrence of death, myocardial infarction and heart failure
|
1 year after inclusion
|
Undiagnosed COPD
Time Frame: 2 months
|
percentage of patients admitted to hospital for ACS and with undiagnosed COPD
|
2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 1 year after inclusion
|
hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia
|
1 year after inclusion
|
Cardiac Death
Time Frame: 1 year
|
occurrence of cardiac death
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gianluca Campo, MD, University Hospital of Ferrara
- Principal Investigator: Marco Contoli, MD, University Hospital of Ferrara
Publications and helpful links
General Publications
- Campo G, Pavasini R, Barbetta C, Maietti E, Mascetti S, Biscaglia S, Zaraket F, Spitaleri G, Gallo F, Tonet E, Papi A, Ferrari R, Contoli M. Predischarge screening for chronic obstructive pulmonary disease in patients with acute coronary syndrome and smoking history. Int J Cardiol. 2016 Nov 1;222:806-812. doi: 10.1016/j.ijcard.2016.08.030. Epub 2016 Aug 4.
- Erriquez A, Pavasini R, Biscaglia S, Tebaldi M, Tonet E, Maietti E, Cimaglia P, Grazzi G, Scoccia A, Cardelli LS, Verardi FM, Morelli C, Campana R, Rubboli A, Mazzoni G, Volpato S, Ferrari R, Campo G. The impact of periprocedural myocardial infarction on mortality in older adults with non-ST-segment elevation acute coronary syndrome: a pooled analysis of the FRASER and HULK studies. J Cardiovasc Med (Hagerstown). 2021 Jul 1;22(7):546-552. doi: 10.2459/JCM.0000000000001146.
- Pavasini R, Fiorencis A, Tonet E, Gaudenzi E, Balla C, Maietti E, Biscaglia S, Papi A, Ferrari R, Contoli M, Campo G. Right Ventricle Function in Patients with Acute Coronary Syndrome and Concomitant Undiagnosed Chronic Obstructive Pulmonary Disease. COPD. 2019 Aug;16(3-4):284-291. doi: 10.1080/15412555.2019.1645105. Epub 2019 Jul 29.
- Pavasini R, Vieceli Dalla Sega F, Gallo F, Passarini G, Papi A, Contoli M, Campo G. Endothelial dysfunction and increased platelet reactivity in patients with acute coronary syndrome and undiagnosed COPD: insights into the SCAP trial. Eur Respir J. 2017 Oct 5;50(4):1701183. doi: 10.1183/13993003.01183-2017. Print 2017 Oct. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 131295
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on screening test
-
Massachusetts General HospitalUniversity of California, Los Angeles; Stand Up To Cancer; Great Plains Tribal...Enrolling by invitationColorectal CancerUnited States
-
Centre Hospitalier Universitaire de NiceCompleted
-
University Hospital, ToursCompletedUterine Cervical Neoplasms | Uterine Cervical DysplasiaFrance
-
National Taipei University of Nursing and Health...Wei Gong Memorial HospitalRecruiting
-
Emanuele BosiItalian Diabetes FoundationCompletedAutoimmune Diseases | Cardiovascular Risk FactorsItaly
-
John Wesson Ashford JrUS Department of Veterans AffairsActive, not recruiting
-
Portland VA Medical CenterCompleted
-
IRCCS Burlo GarofoloRecruiting
-
POC Medical Systems, Inc.Unknown