Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease
Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease; Potential Role for Systemic Biomarkers (Krebs Von Den Lungen-6 (KL-6))
A group of Interstitial pulmonary fibrosis will be recruited from Assiut university hospital outpatient clinic.
Evaluation will be done regarding cardiovascular comorbidities (Cardiovascular comorbidities will be evaluated with thorough assessment including; history, ECG, Lipid profile and echocardiography).
Lipid profile, CRP and KL-6 level will be assessed for recruited personnel. Regression analysis will be used to identify risk factors for cardiovascular comorbidities among IPF patients.
Study Overview
Status
Intervention / Treatment
Detailed Description
Interstitial lung disease (ILD) is a chronic, progressive, parenchymal disease of the lungs. ILD has been associated with various cardiovascular co-morbidities, such as coronary artery disease (CAD) and heart failure (HF). So far, little is known regarding the cardiovascular co-morbidities in patients with idiopathic pulmonary fibrosis (IPF), the most aggressive form of ILD.
Blood biomarkers have been shown to emerging evidence in patients with IPF in clinical practice. Several blood biomarkers, including lung-epithelium specific proteins, chemokines, growth factors, proteases, and other serological markers, have been studied widely in the fields of diagnosis, disease severity, and prognosis in patients with IPF. Among them, Krebs von den Lungen-6 (KL-6) is used in clinical practice and elevated level of KL-6 is known to predict mortality in patients with IPF.
It is well documented that fibrosis is closely linked to the inflammatory response. Emerging evidence suggests that cardiac fibrosis in general is primarily due to complications associated with acute and prolonged inflammation, suggesting that even low-grade, persistent inflammation is enough to promote cardiac fibrosis. The cellular and molecular events that underpin the inflammatory processes in cardiac disease are complex and poorly understood, with many tissue and disease specific mechanisms.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Asyut, Egypt, 711111
- Faculty of medicine, Assiut university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Demographic characteristics of patients diagnosed with interstitial pulmonary fibrosis and recruited from Assiut university hospital outpatient clinic will be recorded, including sex, age, smoking status, underlying comorbidities, addiction status.
Chest symptoms evaluation: Cough, expectoration, hemoptysis, dyspnea, wheeze and chest pain.
Comorbidity evaluation; including DM, hypertension, hepatic diseases, renal diseases.
Cardiovascular comorbidities thorough assessment including; ECG, Lipid profile and echocardiography.
chest radiograph and computed tomography (CT) chest findings will be assessed. Laboratory investigations: Lipid profile, CRP and KL-6 level according to the manufacturer's instructions
Description
Inclusion Criteria:
- Patients diagnosed as Interstitial pulmonary fibrosis
Exclusion Criteria:
- Patients refusing to participate in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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percentage of patients with IPF who develop cardiovascular comorbidities
Time Frame: 6 months
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Prevalence, clinical pattern of cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
Time Frame: 6 months
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accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waleed MD Gamal Elddin Khaleel, Ass. Prof., Assiut University
Publications and helpful links
General Publications
- Agrawal A, Verma I, Shah V, Agarwal A, Sikachi RR. Cardiac manifestations of idiopathic pulmonary fibrosis. Intractable Rare Dis Res. 2016 May;5(2):70-5. doi: 10.5582/irdr.2016.01023.
- Nathan SD, Basavaraj A, Reichner C, Shlobin OA, Ahmad S, Kiernan J, Burton N, Barnett SD. Prevalence and impact of coronary artery disease in idiopathic pulmonary fibrosis. Respir Med. 2010 Jul;104(7):1035-41. doi: 10.1016/j.rmed.2010.02.008. Epub 2010 Mar 2.
- Stainer A, Faverio P, Busnelli S, Catalano M, Della Zoppa M, Marruchella A, Pesci A, Luppi F. Molecular Biomarkers in Idiopathic Pulmonary Fibrosis: State of the Art and Future Directions. Int J Mol Sci. 2021 Jun 10;22(12):6255. doi: 10.3390/ijms22126255.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WGEK72024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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