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
1 other identifier
observational
225
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedApril 8, 2022
March 1, 2022
2.7 years
March 31, 2022
March 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Protein composition in tissue
Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Baseline
Metabolomic composition
Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Baseline
Secondary Outcomes (6)
Biomarker composition
Baseline
Biomarker composition
Within 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
With 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
3 years
Protein composition
Within 12 months
- +1 more secondary outcomes
Study Arms (5)
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
Eligibility Criteria
Patients who have their angioplasty or vascular surgery at the Copenhagen University hospital (Rigshospitalet) or Herlev-Gentofte hospital
You may qualify if:
- Symptomatic atherosclerotic disease
- years or older
- Angioplasty or vascular surgery
You may not qualify if:
- \- Not willing or unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- University of Copenhagencollaborator
- Herlev and Gentofte Hospitalcollaborator
Study Sites (2)
The Heart Centre
Copenhagen, 2100, Denmark
Herlev-Gentofte
Gentofte Municipality, 2820, Denmark
Biospecimen
Tissue samples from the baloon catherther or vascular surgery and blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gorm M Hansen, MD, PhD
The Heart Center, Rigshospitalet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 8, 2022
Study Start
December 1, 2021
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
April 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share