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Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

NCT05319366 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2022-04-08

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Gorm M Hansen, MD, PhD · The Heart Center, Rigshospitalet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319366 on ClinicalTrials.gov