AtherosclerosisByPlaqueNCT03774004
Plaque Burden Pre- Myocardial Revascularisation
An observational study of Atherosclerosis, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Atherosclerosis
- How many people
- 252 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2018to 1 Jul 2021
- 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 30 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients, who are are listed for elective CABG at the Medical University Innsbruck will be screened and recruited.
Who may be able to join
- pre CABG
Who cannot join
- no consent, prior carotid intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation
The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG).
Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG.
Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of MACE rates with peripheral atherosclerotic volume
Measured: 5 years
Association of morbidity with peripheral atherosclerotic volume
Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"
Measured: 5 years
Secondary outcomes (6)
Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions
Risk scores include STS Score and Euro Score
Measured: 1 year
Association of the duration of the operation with peripheral atherosclerotic volume
Measured: 30 days
Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates
Measured: 5 years
Association of the aortic clamp time with peripheral atherosclerotic volume
Measured: 30 days
Association of the ICU stay with peripheral atherosclerotic volume
Measured: 30 days
Association of the hospitalization duration with peripheral atherosclerotic volume
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Marschang, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774004
- Sponsor's protocol ID
- 1098/2017
- Acronym
- ByPlaque
- Status last verified
- Oct 2023
- First submitted
- 11 Dec 2018
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation
- ClinicalTrials.gov ID
- NCT03774004
- Acronym / sponsor ID
- ByPlaque / 1098/2017
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 12 Dec 2018 (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 study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG).
Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG.
Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients, who are are listed for elective CABG at the Medical University Innsbruck will be screened and recruited.
Key inclusion criteria (1 listed)
- pre CABG
Key exclusion criteria (1 listed)
- no consent, prior carotid intervention
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
Association of MACE rates with peripheral atherosclerotic volume
Time frame: 5 years
Association of morbidity with peripheral atherosclerotic volume
Time frame: 5 years
Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"
6 secondary outcomes
Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions
Time frame: 1 year
Association of the duration of the operation with peripheral atherosclerotic volume
Time frame: 30 days
Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates
Time frame: 5 years
Association of the aortic clamp time with peripheral atherosclerotic volume
Time frame: 30 days
Association of the ICU stay with peripheral atherosclerotic volume
Time frame: 30 days
Association of the hospitalization duration with peripheral atherosclerotic volume
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
Peter Marschang, MD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Medical University Innsbruck at 1 site in Austria.
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 1 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: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of MACE rates with peripheral atherosclerotic volume (time frame: 5 years). 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 23 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.