Maastricht Biomarker CT Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01671930
First received: August 21, 2012
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

Introduction

Cardiovascular disease is the leading cause of death in the Western world. The main cause for cardiovascular events is the development of atherosclerosis in the coronary arteries. In more than 70% of cases, myocardial infarctions are caused by atherosclerotic plaque rupture, which results in subsequent formation of an occluding thrombus. Plaques that have a high risk of rupture are called vulnerable plaques. Cardiovascular imaging provides a complementary diagnostic approach in the assessment of cardiovascular risk in patients. However, the lack of biological detection possibilities of current imaging technologies limits their predictive value. For instance, multi detector computed tomography (MDCT) is an excellent tool to visualize coronary atherosclerosis. However, individual risk assessment is still problematic. Which of the diagnosed atherosclerotic plaques will undergo plaque rupture and lead to acute vascular events is currently hard to predict. Potentially, serum biomarkers could help identify the patient at risk. A wide variety of prognostic markers related to atherosclerosis have been identified in the past to predict for cardiovascular events. Nevertheless, their predictive value in individual patients is still limited. A difficulty in serum biomarker research is the requirement of large patient cohorts to study the relation between event rate and serum biomarker levels. The necessity to perform lengthy and costly studies, hinders the translation of novel cardiovascular serum biomarkers into the clinic. An alternative approach could be to study the correlation between levels of serum biomarkers and the presence of atherosclerosis in the coronary arteries.

Study objectives

Primary objective of the present analysis is to investigate the predictive value of a variety of serum biomarkers to predict atherosclerosis in the coronary tree of patients undergoing cardiac MDCT.

Design and Methods

Patients undergoing cardiac MDCT are eligible for the study. Excluded are patients with acute coronary syndrome, hemodynamic instability, pregnancy, severe renal insufficiency, allergy for contrast medium and inability to obtain informed consent. Permission to store the serum samples for future analysis of new prognostic markers for cardiovascular events will be acquired from the patients. Written information is send to the patient at least 1 week prior to CT. The samples will be stored coded, at the Biobank Maastricht, for a maximum duration of 15 years. Once measurements from the samples will be performed, the serum samples will be sent by the Biobank coded to the analyzing researchers, which have no access to the key file where codes are linked to the specific hospital identity number. This file will be stored by an independent researcher at the Cardiology department of the Maastricht University Medical Center. The assessment of atherosclerotic burden of the coronary tree will be performed by cardiac MDCT specialists blinded to the clinical data and serum biomarker outcome. Biomarker levels are correlated to the severity and amount of coronary artery disease as assessed by cardiac MDCT.


Condition
Coronary Artery Disease
Coronary Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Maastricht Biomarker CT Study. Relation Between Cardiovascular Biomarkers and Coronary Atherosclerosis in Patients Undergoing Multi Detector Cardiac Computed Tomography.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • coronary artery disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • The presence of any coronary atherosclerotic plaque as visible on cardiac CT.
    • The presence of any significant (≥50% luminal stenosis) coronary plaque in the coronary tree.
    • The number of atherosclerotic plaques in the coronary tree.
    • The calcium score (Agatston method).
    • Plaques are categorized as calcified (exclusively content with density >130 Hounsfield units), non-calcified (exclusively content with density <130 Hounsfield units), or mixed (characteristics of both calcified and non-calcified plaque).


Enrollment: 5000
Study Start Date: April 2007
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiac computed tomographic angiography
Patients refered for cardiac computed tomographic angiography by a cardiologist.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that were refered to undergo cardiac computed tomography by their cardiologist, to exclude coronary artery disease. Location: tertiary academic hospital.

Criteria

Inclusion Criteria:

  • patients refered to cardiac computed tomography to exclude coronary artery disease

Exclusion Criteria:

  • pregnancy
  • severe renal insufficiency
  • severe allergy to contrast medium
  • Inability to obtain informed consent
  • Age below 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671930

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: H Crijns, M.D. P.h.D. Maastricht University Medical Center
Study Director: B Kietselaer, M.D. P.h.D. Maastricht University Medical Center
Study Chair: L Hofstra, M.D. P.h.D Maastricht University Medical Center
  More Information

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01671930     History of Changes
Other Study ID Numbers: MEC 08-4-057
Study First Received: August 21, 2012
Last Updated: May 26, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014