Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

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

• Registration Number: NCT05319366
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

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

Exclusion Criteria

• Not willing or unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protein composition in tissue	Baseline	Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Metabolomic composition	Baseline	Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.

Secondary Outcome Measures

Name	Time	Method
Disease progression in relation to protein, metabolite and biomarker compostion	3 years	Changes in disease progression in relation to the protein, metabolite and biomarker composition
Biomarker composition	Within 12 months	Differences in biomarker composition between groups
Protein composition	Within 12 months	Difference in protein composition in blood samples
Metabolomic composition	Within 12 months	Difference in metabolite composition in blood samples

Trial Locations

Locations (2)

Herlev-Gentofte; 🇩🇰 Gentofte, Denmark

The Heart Centre; 🇩🇰 Copenhagen, Denmark