Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).

March 31, 2022 updated by: Gorm Mork, Rigshospitalet, Denmark

Proteomics- og Metabolomics-undersøgelse af Materiale Ekstraheret Fra Ballonkatetre Anvendt Til Ballon-udvidelsesbehandling Hos Patienter Med Symptomatisk åreforkalkningssygdom

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Not willing or unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein composition in tissue
Time Frame: Baseline
Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Baseline
Metabolomic composition
Time Frame: Baseline
Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker composition
Time Frame: Baseline
Differences in biomarker composition between groups
Baseline
Biomarker composition
Time Frame: Within 12 months
Differences in biomarker composition between groups
Within 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
Time Frame: With 12 months
Changes in disease progression in relation to the protein, metabolite and biomarker composition
With 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
Time Frame: 3 years
Changes in disease progression in relation to the protein, metabolite and biomarker composition
3 years
Protein composition
Time Frame: Within 12 months
Difference in protein composition in blood samples
Within 12 months
Metabolomic composition
Time Frame: Within 12 months
Difference in metabolite composition in blood samples
Within 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen
Herlev and Gentofte Hospital

Investigators

  • Principal Investigator: Gorm M Hansen, MD, PhD, The Heart Center, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2021

Primary Completion (ANTICIPATED)

July 31, 2024

Study Completion (ANTICIPATED)

July 31, 2024

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (ACTUAL)

April 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21029011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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