Angina, StableNCT05319366
Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).
An observational study of Angina, Stable and Angina, Unstable, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Stable, Angina, Unstable, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
- How many people
- 225 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Dec 2021to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have their angioplasty or vascular surgery at the Copenhagen University hospital (Rigshospitalet) or Herlev-Gentofte hospital
Who may be able to join
- Symptomatic atherosclerotic disease
- 18 years or older
- Angioplasty or vascular surgery
Who cannot join
- Not willing or unable to give informed consent
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
The Heart Centre
Copenhagen, 2100
Gorm M Hansen, MD, PHD, +4535454452, gorm.moerk.hansen@regionh.dk
Henning Bundgaard, PhD, DMSc, +4535450512, Henning.Bundgaard@regionh.dk
- Recruiting
Herlev-Gentofte
Gentofte Municipality, 2820
Kasper K Iversen, MD, DMSc, +45 38683647, Kasper.Karmark.Iversen@regionh.dk
Sune A Haahr-Pedersen, MD, PhD, +45 38672267, sune.ammentorp.haahr-pedersen@regionh.dk
About this study
Official title: 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.
- 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
- Medical subject headings
- Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Vascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Protein composition in tissue
Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Measured: Baseline
Metabolomic composition
Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
Measured: Baseline
Secondary outcomes (6)
Biomarker composition
Differences in biomarker composition between groups
Measured: Baseline
Biomarker composition
Differences in biomarker composition between groups
Measured: Within 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
Changes in disease progression in relation to the protein, metabolite and biomarker composition
Measured: With 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
Changes in disease progression in relation to the protein, metabolite and biomarker composition
Measured: 3 years
Protein composition
Difference in protein composition in blood samples
Measured: Within 12 months
Metabolomic composition
Difference in metabolite composition in blood samples
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Dec 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Gorm Mork, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gorm M Hansen, MD, PhD, Principal investigator, The Heart Center, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319366
- Sponsor's protocol ID
- H-21029011
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics- og Metabolomics-undersøgelse af Materiale Ekstraheret Fra Ballonkatetre Anvendt Til Ballon-udvidelsesbehandling Hos Patienter Med Symptomatisk åreforkalkningssygdom
- ClinicalTrials.gov ID
- NCT05319366
- Acronym / sponsor ID
- H-21029011
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, Herlev and Gentofte Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have their angioplasty or vascular surgery at the Copenhagen University hospital (Rigshospitalet) or Herlev-Gentofte hospital
Key inclusion criteria (3 listed)
- Symptomatic atherosclerotic disease
- 18 years or older
- Angioplasty or vascular surgery
Key exclusion criteria (1 listed)
- Not willing or unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Metabolomic composition
Time frame: Baseline
Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.
6 secondary outcomes
Biomarker composition
Time frame: Baseline
Biomarker composition
Time frame: Within 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
Time frame: With 12 months
Disease progression in relation to protein, metabolite and biomarker compostion
Time frame: 3 years
Protein composition
Time frame: Within 12 months
Metabolomic composition
Time frame: Within 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gorm M Hansen, MD, PhD principal investigator
The Heart Center, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, Stable and Angina, Unstable, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gorm M Hansen, MD, PhD (+45 35454452, gorm.moerk.hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein composition in tissue (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.