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

NCT02324660 | Completed Results DMC

• 1 other identifier: 131295
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Acute Coronary Syndromes

Keywords

screening procedure; peak expiratory flow; respiratory health screening questionnaire

Outcome Measures

Primary Outcomes (1)

• COPD Diagnosis

  COPD diagnosis confirmed by spirometry

  2 months after inclusion

Secondary Outcomes (2)

• Cardiac Adverse Events

  1 year after inclusion

• Undiagnosed COPD

  2 months

Other Outcomes (2)

• Adverse Events

  1 year after inclusion

• Cardiac Death

  1 year

Study Arms (1)

screening test

OTHER

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

Interventions

screening test OTHER

screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD

screening test

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related Publications (4)

• 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: 27522379 RESULT

• 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: 34076602 DERIVED

• 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: 31357891 DERIVED

• 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.

  PMID: 28982765 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Acute Coronary Syndrome

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Results Point of Contact

• Title: Gianluca Campo, PI of the study
• Organization: Azienda Ospedaliera Universitaria di Ferrara

cmpglc@unife.it

0532237079

Study Officials

• Gianluca Campo, MD

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

• Marco Contoli, MD

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 7, 2017
• Results First Posted: August 7, 2017

Record last verified: 2017-05

Locations

IT (1)