Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT05319366

Collaborator

University of Copenhagen (Other), Herlev and Gentofte Hospital (Other)

225

Enrollment

Locations

Anticipated Duration (Months)

112.5

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Angina, Stable Angina, Unstable Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) ST-segment Elevation Myocardial Infarction (STEMI) Vascular Diseases

Study Design

Study Type:

Observational

Anticipated Enrollment :

225 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Stable angina 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 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 50 patients with ST-segment elevation myocardial infarction will be included and tissue samples from balloon cathether and blood samples will be collected
Controls 50 patients without corornary arthery-related treatment will be included and tissue samples from balloon cathether and blood samples will be collected
Vascular surgery 25 patients who undergo will be included and tissue samples and blood samples will be collected

Outcome Measures

Primary Outcome Measures

Protein composition in tissue [Baseline]
Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Metabolomic composition [Baseline]
Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.

Secondary Outcome Measures

Biomarker composition [Baseline]
Differences in biomarker composition between groups
Biomarker composition [Within 12 months]
Differences in biomarker composition between groups
Disease progression in relation to protein, metabolite and biomarker compostion [With 12 months]
Changes in disease progression in relation to the protein, metabolite and biomarker composition
Disease progression in relation to protein, metabolite and biomarker compostion [3 years]
Changes in disease progression in relation to the protein, metabolite and biomarker composition
Protein composition [Within 12 months]
Difference in protein composition in blood samples
Metabolomic composition [Within 12 months]
Difference in metabolite composition in blood samples