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Clinical Trials/NCT05319366
NCT05319366
Unknown
Not Applicable

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

Rigshospitalet, Denmark2 sites in 1 country225 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Angina, Stable
Sponsor
Rigshospitalet, Denmark
Enrollment
225
Locations
2
Primary Endpoint
Protein composition in tissue
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
July 31, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gorm Mork

MD, PhD

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not willing or unable to give informed consent

Outcomes

Primary Outcomes

Protein composition in tissue

Time Frame: Baseline

Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.

Metabolomic composition

Time Frame: Baseline

Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.

Secondary Outcomes

  • Disease progression in relation to protein, metabolite and biomarker compostion(3 years)
  • Biomarker composition(Within 12 months)
  • Protein composition(Within 12 months)
  • Metabolomic composition(Within 12 months)

Study Sites (2)

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