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Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05319366
Enrollment
225
Registered
2022-04-08
Start date
2021-12-01
Completion date
2024-07-31
Last updated
2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Proteomics, Metabolomics, Atherosclerosis, Angioplasty, Vascular surgery

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.

Interventions

None listed

Sponsors

University of Copenhagen
CollaboratorOTHER
Herlev and Gentofte Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Symptomatic atherosclerotic disease * 18 years or older * Angioplasty or vascular surgery

Exclusion criteria

\- Not willing or unable to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Protein composition in tissueBaselineDifference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Metabolomic compositionBaselineDifference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.

Secondary

MeasureTime frameDescription
Biomarker compositionBaselineDifferences in biomarker composition between groups
Disease progression in relation to protein, metabolite and biomarker compostionWith 12 monthsChanges in disease progression in relation to the protein, metabolite and biomarker composition
Protein compositionWithin 12 monthsDifference in protein composition in blood samples
Metabolomic compositionWithin 12 monthsDifference in metabolite composition in blood samples

Countries

Denmark

Contacts

Primary ContactGorm M Hansen, MD, PhD
gorm.moerk.hansen@regionh.dk+45 35454452
Backup ContactHenning Bundgaard, PhD, DMSci
Henning.Bundgaard@regionh.dk+4535450512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026