Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT02324660
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cmpglc@unife.it', 'phone': '0532237079', 'title': 'Gianluca Campo, PI of the study', 'phoneExt': '+39', 'organization': 'Azienda Ospedaliera Universitaria di Ferrara'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Undergoing Screening and Spirometry', 'description': 'From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if \\<80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if \\>19.5 points). Overall, 137 (81%) patients received spirometry (final study population)', 'otherNumAtRisk': 137, 'otherNumAffected': 0, 'seriousNumAtRisk': 137, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'COPD Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Undergoing Screening and Spirometry', 'description': 'From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if \\<80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if \\>19.5 points). Overall, 137 (81%) patients received spirometry (final study population)'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months after inclusion', 'description': 'COPD diagnosis confirmed by spirometry', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Test', 'description': '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).\n\nscreening test: screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after inclusion', 'description': 'cumulative occurrence of death, myocardial infarction and heart failure', 'unitOfMeasure': 'partecipants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Undiagnosed COPD', 'timeFrame': '2 months', 'description': 'percentage of patients admitted to hospital for ACS and with undiagnosed COPD', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events', 'timeFrame': '1 year after inclusion', 'description': 'hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cardiac Death', 'timeFrame': '1 year', 'description': 'occurrence of cardiac death', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Undergoing Screening and Spirometry', 'description': 'From December 2014 to August 2015, 169 ACS patients with smoking history underwent screening procedure. Screening procedure combined peak expiratory flow rate (PEFR, defined as positive if \\<80% of predicted) and respiratory health status questionnaire (RHSQ, defined as positive if \\>19.5 points). Overall, 137 (81%) patients received spirometry (final study population)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}]}], 'recruitmentDetails': 'From December 2014 to August 2015, 169 acute cornary syndromes patients with smoking history underwent screening procedure in the University Hospital of Ferrara'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Undergoing Screening and Spirometry'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2014-12-18', 'resultsFirstSubmitDate': '2016-08-10', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-01', 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year after inclusion', 'description': 'hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia'}, {'measure': 'Cardiac Death', 'timeFrame': '1 year', 'description': 'occurrence of cardiac death'}], 'primaryOutcomes': [{'measure': 'COPD Diagnosis', 'timeFrame': '2 months after inclusion', 'description': 'COPD diagnosis confirmed by spirometry'}], 'secondaryOutcomes': [{'measure': 'Cardiac Adverse Events', 'timeFrame': '1 year after inclusion', 'description': 'cumulative occurrence of death, myocardial infarction and heart failure'}, {'measure': 'Undiagnosed COPD', 'timeFrame': '2 months', 'description': 'percentage of patients admitted to hospital for ACS and with undiagnosed COPD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['screening procedure', 'peak expiratory flow', 'respiratory health screening questionnaire'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Acute Coronary Syndromes']}, 'referencesModule': {'references': [{'pmid': '27522379', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34076602', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31357891', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '28982765', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'BACKGROUND:\n\nAcute 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.\n\nHYPOTHESIS and SIGNIFICANCE:\n\nBased 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.\n\nMETHODS:\n\nBlood 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.\n\nScreening 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.\n\nSpirometry: spirometry test will be performed 50-70 days after hospital discharge (enrollment time).\n\nPrimary 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.\n\nClinical 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.\n\nBiological 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.\n\nSecondary outcomes: PEF, RHSQ, biological parameters and spirometry results will be related to clinical outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>40 years\n* typical chest pain during at least 20 minutes\n* ST-segment changes on electrocardiography, indicating ischemia and/or positive test of a biomarker (troponin and/or CK-MB), indicating myocardial necrosis\n* current or former history of smoking\n\nExclusion Criteria:\n\n* previous diagnosis of COPD and/or asthma\n* known pulmonary disease\n* ongoing pneumonia\n* ongoing heart failure\n* documented or suspicion of malignant disease\n* life expectancy \\<1 year\n* recent thoracic trauma'}, 'identificationModule': {'nctId': 'NCT02324660', 'acronym': 'SCAP', 'briefTitle': 'Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Prospective Evaluation of a Screening Methodology for Chronic Obstructive Pulmonary Disease in Patients Admitted to Hospital for Acute Coronary Syndromes.', 'orgStudyIdInfo': {'id': '131295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'screening test', 'description': '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).', 'interventionNames': ['Other: screening test']}], 'interventions': [{'name': 'screening test', 'type': 'OTHER', 'description': 'screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD', 'armGroupLabels': ['screening test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Cona', 'state': 'Ferrara', 'country': 'Italy', 'facility': 'University Hospital of Ferrara', 'geoPoint': {'lat': 44.80583, 'lon': 11.7069}}], 'overallOfficials': [{'name': 'Gianluca Campo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Ferrara'}, {'name': 'Marco Contoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Ferrara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gianluca Campo', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}