Coronary Artery DiseasePARSEC-NETNCT02394262
Sequential Coronary CT-angiography and Biomarkers
A study testing Coronary CT-angiography and Assesment of biomarkers involved in atherothrombosis in people with Coronary Artery Disease and Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Coronary CT-angiography and Assesment of biomarkers involved in atherothrombosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA.
- Age older than 18 years and competent to perform written informed consent.
- At least 2 coronary segments with plaques:
- 1 proximal lesion.
- At least one coronary plaque consisting of a non-calcified or mixed component.
Who cannot join
- Unstable angina.
- Renal insufficiency: calculated estimated glomerular filtration rate <45mL/min.
- Iodine allergy.
- Pregnancy.
- Known history of atrial fibrillation.
- Inconclusive baseline computed coronary CT-angiography.
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- Patients which are currently on oral vitamin K antagonists.
- Patients which are currently using selective anticoagulants.
- Previous PCI.
- Previous or planned coronary artery bypass grafting.
- Patients whereby the baseline CCTA was performed by a retrospective ECG-gated 'helical' protocol due to a high (>90bpm) or irregular heart rate.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202
About this study
Official title: Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers
Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- Coronary CT-angiography, Assesment of biomarkers involved in atherothrombosis
- Keywords
- Biological Markers, Multidetector Computed Tomography
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT-angiographyRadiation
Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).
Assesment of biomarkers involved in atherothrombosisOther
Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Serial CCTA and atherothrombosis markers | Experimental | Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up. Receives: Radiation: Coronary CT-angiography; Other: Assesment of biomarkers involved in atherothrombosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque progression as defined by sequential CCTA using dedicated software.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bas Kietselaer, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394262
- Sponsor's protocol ID
- NL49261.068.14
- Acronym
- PARSEC-NET
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers
- ClinicalTrials.gov ID
- NCT02394262
- Acronym / sponsor ID
- PARSEC-NET / NL49261.068.14
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- Biological Markers, Multidetector Computed Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 20 Mar 2015 (estimated)
- 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.
Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serial CCTA and atherothrombosis markers | Experimental | Radiation: Coronary CT-angiography, Other: Assesment of biomarkers involved in atherothrombosisSequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA.
- Age older than 18 years and competent to perform written informed consent.
- At least 2 coronary segments with plaques:
- 1 proximal lesion.
- At least one coronary plaque consisting of a non-calcified or mixed component.
Key exclusion criteria (11 listed)
- Unstable angina.
- Renal insufficiency: calculated estimated glomerular filtration rate <45mL/min.
- Iodine allergy.
- Pregnancy.
- Known history of atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT-angiographySequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department). | Radiation | Serial CCTA and atherothrombosis markers |
| Assesment of biomarkers involved in atherothrombosisSequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up. | Other | Serial CCTA and atherothrombosis markers |
Primary outcome
Plaque progression as defined by sequential CCTA using dedicated software.
Time frame: 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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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.
Bas Kietselaer, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary CT-angiography and Assesment of biomarkers involved in atherothrombosis in people with Coronary Artery Disease and Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 11 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 28 Mar 2017. 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 Netherlands. 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 Bas Kietselaer, MD, PhD (+31433871587, b.kietselaer@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque progression as defined by sequential CCTA using dedicated software. (time frame: 1 year.). 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 28 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.