Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

Study Overview
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Brief Summary
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The purpose of the study is to identify proteins, metabolites and signal pathways related directly to symptomatic atherosclerosis and to disease progression. In the study, we use residual material from angioplasty catheter balloons and from vascular surgery plus blood samples. It is the hypothesis that material left on the catheter balloons used for angioplasty can be used for proteomics and metabolomics evaluation that will identify inflammation-associated proteins and signaling pathways directly in the diseased vessel. The tissue samples will be collected after the procedure and blood samples will be collected at the procedure plus after 6-12 months. The tissue and blood samples will be analyzed using mass spectrometry methods and a standard panel of biomarkers will also be analyzed using standardized methods. The analyses will include study of inflammation-associated peptides observed in autoinflammation as well as thrombogenic signaling pathways and local expression of biomarkers. The analyses of proteins, metabolites and/or biomarkers will be compared between cases (stable angina, unstable angina/non-STEMI, STEMI and vascular surgery) and controls (procedures not related to coronary artery diseases) to identify molecular processes related directly to symptomatic atherosclerosis and will be associated with disease progression using data from medical journals and National Health registries. The study will recruit 225 patients from Rigshospitalet University Hospital, Copenhagen, and Herlev-Gentofte Hospital.

Official Title
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Proteomics- og Metabolomics-undersøgelse af Materiale Ekstraheret Fra Ballonkatetre Anvendt Til Ballon-udvidelsesbehandling Hos Patienter Med Symptomatisk åreforkalkningssygdom

Conditions
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Angina, Stable, Angina, Unstable, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), ST-segment Elevation Myocardial Infarction (STEMI), Vascular Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic atherosclerotic disease 18 years or older Angioplasty or vascular surgery Exclusion Criteria: - Not willing or unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stable angina<br>50 patients with stable angina will be included and tissue samples from balloon cathether and blood samples will be collected | |
| Unstable angina/non-ST-segment elevation myocardial infarction<br>50 patients with unstable angina/non-ST-segment elevation myocardial infarction will be included and tissue samples from balloon cathether and blood samples will be collected | |
| ST-segment elevation myocardial infarction<br>50 patients with ST-segment elevation myocardial infarction will be included and tissue samples from balloon cathether and blood samples will be collected | |
| Controls<br>50 patients without corornary arthery-related treatment will be included and tissue samples from balloon cathether and blood samples will be collected | |
| Vascular surgery<br>25 patients who undergo will be included and tissue samples and blood samples will be collected | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein composition in tissue | Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups. | Baseline | 
| Metabolomic composition | Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker composition | Differences in biomarker composition between groups | Baseline | 
| Biomarker composition | Differences in biomarker composition between groups | Within 12 months | 
| Disease progression in relation to protein, metabolite and biomarker compostion | Changes in disease progression in relation to the protein, metabolite and biomarker composition | With 12 months | 
| Disease progression in relation to protein, metabolite and biomarker compostion | Changes in disease progression in relation to the protein, metabolite and biomarker composition | 3 years | 
| Protein composition | Difference in protein composition in blood samples | Within 12 months | 
| Metabolomic composition | Difference in metabolite composition in blood samples | Within 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteomics, Metabolomics, Atherosclerosis, Angioplasty, Vascular surgery