Biomarkers and Cardiac CT

March 27, 2017 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202AZ
        • Recruiting
        • Maastricht University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: Venous blood sampling prior to CCTA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Data registration of patients undergoing CCTA and given written informed consent.
Time Frame: 15 years.
15 years.
To detect these patients for cardiovascular disease and Long term CV outcome (MACE).
Time Frame: 15 years.
15 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
The relationship of novel blood biomarkers with CCTA findings.
Time Frame: 15 years.
15 years.
The predictive value of these biomarkers to predict CAD in patients undergoing CCTA.
Time Frame: 15 years.
15 years.
The prognostic value of these biomarkers (in combination) to predict MACE.
Time Frame: 15 years.
15 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Bas Kietselaer, MD, PhD, Maastricht University Medical Center
  • Study Chair: Harry J Crijns, MD, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2029

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 14-4-117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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