Biomarkers and Cardiac CT

NCT ID: NCT02381301

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Venous blood sampling prior to CCTA.

Intervention Type BIOLOGICAL

Interventions

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Venous blood sampling prior to CCTA.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry J Crijns, MD, PhD

Role: STUDY_CHAIR

Maastricht University Medical Center

Bas Kietselaer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Bas Kietselaer, MD, PhD

Role: CONTACT

+31433871587

Sibel Altintas, MD

Role: CONTACT

+31433881232

Facility Contacts

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Bas L Kietselaer, MD, PhD

Role: primary

Other Identifiers

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METC 14-4-117

Identifier Type: -

Identifier Source: org_study_id

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