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NCT05319366 Clinical Trial

Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

Vascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05319366
Other study ID # H-21029011
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date July 31, 2024

Study information
Verified date March 2022
Source Rigshospitalet, Denmark
Contact Gorm M Hansen, MD, PhD
Phone +45 35454452
Email gorm.moerk.hansen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 225
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Symptomatic atherosclerotic disease - 18 years or older - Angioplasty or vascular surgery Exclusion Criteria: - Not willing or unable to give informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark The Heart Centre Copenhagen
Denmark Herlev-Gentofte Gentofte

Sponsors (3)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Herlev and Gentofte Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Protein composition in tissue Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups. Baseline
Primary Metabolomic composition Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups. Baseline
Secondary Biomarker composition Differences in biomarker composition between groups Baseline
Secondary Biomarker composition Differences in biomarker composition between groups Within 12 months
Secondary 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
Secondary 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
Secondary Protein composition Difference in protein composition in blood samples Within 12 months
Secondary Metabolomic composition Difference in metabolite composition in blood samples Within 12 months
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