Biomarkers and Cardiac CT
Biomarkers and Cardiac Computed Tomography: Relationship Between Cardiovascular Biomarkers and Coronary Artery Disease in Patients Undergoing Cardiac Computed Tomography
1 other identifier
observational
5,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
March 28, 2017
March 1, 2017
14.8 years
March 2, 2015
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Data registration of patients undergoing CCTA and given written informed consent.
15 years.
To detect these patients for cardiovascular disease and Long term CV outcome (MACE).
15 years.
Secondary Outcomes (3)
The relationship of novel blood biomarkers with CCTA findings.
15 years.
The predictive value of these biomarkers to predict CAD in patients undergoing CCTA.
15 years.
The prognostic value of these biomarkers (in combination) to predict MACE.
15 years.
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients referred from the Cardiology clinic for routine CCTA for diagnostic purposes, will be included in this study, after given written informed consent.
You may qualify if:
- Patients referred from the Cardiology clinic for routine CCTA.
You may not qualify if:
- Pregnancy
- Severe renal insufficiency
- Severe allergy to contrast medium
- Inability to obtain informed consent
- Age below 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harry J Crijns, MD, PhD
Maastricht University Medical Center
- PRINCIPAL INVESTIGATOR
Bas Kietselaer, MD, PhD
Maastricht University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 6, 2015
Study Start
February 1, 2015
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
March 28, 2017
Record last verified: 2017-03