Maastricht Biomarker CT Study
|ClinicalTrials.gov Identifier: NCT01671930|
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : May 28, 2014
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.
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 or disease|
|Coronary Artery Disease Coronary Stenosis|
|Study Type :||Observational|
|Actual Enrollment :||5000 participants|
|Official Title:||Maastricht Biomarker CT Study. Relation Between Cardiovascular Biomarkers and Coronary Atherosclerosis in Patients Undergoing Multi Detector Cardiac Computed Tomography.|
|Study Start Date :||April 2007|
|Primary Completion Date :||January 2014|
|Study Completion Date :||January 2014|
cardiac computed tomographic angiography
Patients refered for cardiac computed tomographic angiography by a cardiologist.
- coronary artery disease [ Time Frame: 1 year ]
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671930
|Maastricht University Medical Center|
|Maastricht, Netherlands, 6202 AZ|
|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|