Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

Rigshospitalet

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05319366

H-21029011

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not willing or unable to give informed consent

Trial design

225 participants in 5 patient groups

Stable angina

Description:

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

Description:

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

Description:

50 patients with ST-segment elevation myocardial infarction will be included and tissue samples from balloon cathether and blood samples will be collected

Controls

Description:

50 patients without corornary arthery-related treatment will be included and tissue samples from balloon cathether and blood samples will be collected

Vascular surgery

Description:

25 patients who undergo will be included and tissue samples and blood samples will be collected