Biomarkers and Cardiac CT

Coronary Artery Disease Clinical Trial

Official title:

Biomarkers and Cardiac Computed Tomography: Relationship Between Cardiovascular Biomarkers and Coronary Artery Disease in Patients Undergoing Cardiac Computed Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02381301
• Other study ID #: METC 14-4-117
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 27, 2017
• Start date: February 2015
• Est. completion date: December 2029

Study information

• Verified date: March 2017
• Source: Maastricht University Medical Center
• Contact: Bas Kietselaer, MD, PhD
• Phone: +31433871587
• Email: b.kietsealer[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred from the Cardiology clinic for routine CCTA.

Exclusion Criteria:

• Pregnancy

• Severe renal insufficiency

• Severe allergy to contrast medium

• Inability to obtain informed consent

• Age below 18 years

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Biological:
• Venous blood sampling prior to CCTA.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data registration of patients undergoing CCTA and given written informed consent.		15 years.
Primary	To detect these patients for cardiovascular disease and Long term CV outcome (MACE).		15 years.
Secondary	The relationship of novel blood biomarkers with CCTA findings.		15 years.
Secondary	The predictive value of these biomarkers to predict CAD in patients undergoing CCTA.		15 years.
Secondary	The prognostic value of these biomarkers (in combination) to predict MACE.		15 years.