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Screening for Chronic Obstructive Pulmonary Disease in Patients With Acute Coronary Syndromes (SCAP)

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ClinicalTrials.gov Identifier: NCT02324660
Recruitment Status : Completed
First Posted : December 24, 2014
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Acute Coronary Syndromes Other: screening test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prospective Evaluation of a Screening Methodology for Chronic Obstructive Pulmonary Disease in Patients Admitted to Hospital for Acute Coronary Syndromes.
Study Start Date : December 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Other: screening test
screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD




Primary Outcome Measures :
  1. COPD Diagnosis [ Time Frame: 2 months after inclusion ]
    COPD diagnosis confirmed by spirometry


Secondary Outcome Measures :
  1. Cardiac Adverse Events [ Time Frame: 1 year after inclusion ]
    cumulative occurrence of death, myocardial infarction and heart failure

  2. Undiagnosed COPD [ Time Frame: 2 months ]
    percentage of patients admitted to hospital for ACS and with undiagnosed COPD


Other Outcome Measures:
  1. Adverse Events [ Time Frame: 1 year after inclusion ]
    hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia

  2. Cardiac Death [ Time Frame: 1 year ]
    occurrence of cardiac death



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324660


Locations
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Italy
University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Principal Investigator: Gianluca Campo, MD University Hospital of Ferrara
Principal Investigator: Marco Contoli, MD University Hospital of Ferrara
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gianluca Campo, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT02324660    
Other Study ID Numbers: 131295
First Posted: December 24, 2014    Key Record Dates
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: May 2017
Keywords provided by Gianluca Campo, University Hospital of Ferrara:
screening procedure
peak expiratory flow
respiratory health screening questionnaire
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Respiratory Tract Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases