Clinical trial NCT05319366: Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).
Official title: Proteomics- og Metabolomics-undersøgelse af Materiale Ekstraheret Fra Ballonkatetre Anvendt Til Ballon-udvidelsesbehandling Hos Patienter Med Symptomatisk åreforkalkningssygdom
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Herlev and Gentofte Hospital
First posted: 2022-04-08
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have their angioplasty or vascular surgery at the Copenhagen University hospital (Rigshospitalet) or Herlev-Gentofte hospital

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.


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

Primary outcomes:
measure: Protein composition in tissue
timeFrame: Baseline
measure: Metabolomic composition
timeFrame: Baseline
Secondary outcomes:
measure: Biomarker composition
timeFrame: Baseline
measure: Biomarker composition
timeFrame: Within 12 months
measure: Disease progression in relation to protein, metabolite and biomarker compostion
timeFrame: With 12 months
measure: Disease progression in relation to protein, metabolite and biomarker compostion
timeFrame: 3 years
measure: Protein composition
timeFrame: Within 12 months
measure: Metabolomic composition
timeFrame: Within 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Heart Centre
city: Gentofte
country: Denmark
facility: Herlev-Gentofte
Study officials:
affiliation: The Heart Center, Rigshospitalet
name: Gorm M Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: