Coronary Artery DiseaseNCT02381301
Biomarkers and Cardiac CT
An observational study of Coronary Artery Disease and Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed countries. In addition, many patients suffer from valvular and aortic disease. Although various tools are available to identify patients with cardiovascular (CV) disease at risk for major adverse cardiac events (MACE), the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Venous blood sampling prior to CCTA.
- How many people
- 5,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred from the Cardiology clinic for routine CCTA for diagnostic purposes, will be included in this study, after given written informed consent.
Who may be able to join
- Patients referred from the Cardiology clinic for routine CCTA.
Who cannot join
- Pregnancy
- Severe renal insufficiency
- Severe allergy to contrast medium
- Inability to obtain informed consent
- Age below 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ
Bas L Kietselaer, MD, PhD, b.kietselaer@mumc.nl
About this study
Official title: Biomarkers and Cardiac Computed Tomography: Relationship Between Cardiovascular Biomarkers and Coronary Artery Disease in Patients Undergoing Cardiac Computed Tomography
Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed countries. In addition, many patients suffer from valvular and aortic disease. Although various tools are available to identify patients with cardiovascular (CV) disease at risk for major adverse cardiac events (MACE), the identification of these patients remains a clinical challenge.
One promising avenue is the use of different serum biomarkers involved in atherothrombosis which could provide an easy and cost-effective step in risk stratification.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- Venous blood sampling prior to CCTA.
- 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.
Venous blood sampling prior to CCTA.Biological
| Study group | Role | What they receive |
|---|---|---|
| Venous blood sampling prior to CCTA. | In patients undergoing routine Cardiac Computed Tomography Angiography (CCTA) and given written informed consent blood sampling will be performed. The samples will be stored for a period of 15 years at the Biobank for future analyses. Receives: Biological: Venous blood sampling prior to CCTA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data registration of patients undergoing CCTA and given written informed consent.
Measured: 15 years.
To detect these patients for cardiovascular disease and Long term CV outcome (MACE).
Measured: 15 years.
Secondary outcomes (3)
The relationship of novel blood biomarkers with CCTA findings.
Measured: 15 years.
The predictive value of these biomarkers to predict CAD in patients undergoing CCTA.
Measured: 15 years.
The prognostic value of these biomarkers (in combination) to predict MACE.
Measured: 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry J Crijns, MD, PhD, Study chair, Maastricht University Medical CenterBas Kietselaer, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381301
- Sponsor's protocol ID
- METC 14-4-117
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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
- Biomarkers and Cardiac Computed Tomography: Relationship Between Cardiovascular Biomarkers and Coronary Artery Disease in Patients Undergoing Cardiac Computed Tomography
- ClinicalTrials.gov ID
- NCT02381301
- Acronym / sponsor ID
- METC 14-4-117
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- Biological Markers, Multidetector Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 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.
Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed countries. In addition, many patients suffer from valvular and aortic disease. Although various tools are available to identify patients with cardiovascular (CV) disease at risk for major adverse cardiac events (MACE), the identification of these patients remains a clinical challenge.
One promising avenue is the use of different serum biomarkers involved in atherothrombosis which could provide an easy and cost-effective step in risk stratification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous blood sampling prior to CCTA. | – | Biological: Venous blood sampling prior to CCTA.In patients undergoing routine Cardiac Computed Tomography Angiography (CCTA) and given written informed consent blood sampling will be performed. The samples will be stored for a period of 15 years at the Biobank for future analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred from the Cardiology clinic for routine CCTA for diagnostic purposes, will be included in this study, after given written informed consent.
Key inclusion criteria (1 listed)
- Patients referred from the Cardiology clinic for routine CCTA.
Key exclusion criteria (5 listed)
- Pregnancy
- Severe renal insufficiency
- Severe allergy to contrast medium
- Inability to obtain informed consent
- Age below 18 years
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 |
|---|---|---|
| Venous blood sampling prior to CCTA. | Biological | Venous blood sampling prior to CCTA. |
Primary outcome
Data registration of patients undergoing CCTA and given written informed consent.
Time frame: 15 years.
To detect these patients for cardiovascular disease and Long term CV outcome (MACE).
Time frame: 15 years.
3 secondary outcomes
The relationship of novel blood biomarkers with CCTA findings.
Time frame: 15 years.
The predictive value of these biomarkers to predict CAD in patients undergoing CCTA.
Time frame: 15 years.
The prognostic value of these biomarkers (in combination) to predict MACE.
Time frame: 15 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
Related trials for Coronary Artery Disease
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Harry J Crijns, MD, PhD study chair
Maastricht University Medical Center
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?
An observational study of 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 1 inclusion and 5 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bas Kietselaer, MD, PhD (+31433871587, b.kietsealer@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data registration of patients undergoing CCTA and given written informed consent. (time frame: 15 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 28 Mar 2017; AzTrials last refreshed its copy on 31 Oct 2026.