Biomarkers and Cardiac CT

Recruiting

• Conditions: Coronary Artery Disease; Atherosclerosis
• Interventions: Biological: Venous blood sampling prior to CCTA.

• Registration Number: NCT02381301
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Venous blood sampling prior to CCTA.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands