Clinical trial NCT01671930: Maastricht Biomarker CT Study
Official title: Maastricht Biomarker CT Study. Relation Between Cardiovascular Biomarkers and Coronary Atherosclerosis in Patients Undergoing Multi Detector Cardiac Computed Tomography.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Stenosis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: coronary artery disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: H Crijns, M.D. P.h.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: B Kietselaer, M.D. P.h.D.
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: L Hofstra, M.D. P.h.D
role: STUDY_CHAIR
References:
citation: Mingels AM, Joosen IA, Versteylen MO, Laufer EM, Winkens MH, Wildberger JE, Van Dieijen-Visser MP, Hofstra L. High-sensitivity cardiac troponin T: risk stratification tool in patients with symptoms of chest discomfort. PLoS One. 2012;7(4):e35059. doi: 10.1371/journal.pone.0035059. Epub 2012 Apr 25.
citation: Laufer EM, Mingels AM, Winkens MH, Joosen IA, Schellings MW, Leiner T, Wildberger JE, Narula J, Van Dieijen-Visser MP, Hofstra L. The extent of coronary atherosclerosis is associated with increasing circulating levels of high sensitive cardiac troponin T. Arterioscler Thromb Vasc Biol. 2010 Jun;30(6):1269-75. doi: 10.1161/ATVBAHA.109.200394. Epub 2010 Mar 18.
citation: de Wit-Verheggen VHW, Altintas S, Spee RJM, Mihl C, van Kuijk SMJ, Wildberger JE, Schrauwen-Hinderling VB, Kietselaer BLJH, van de Weijer T. Pericardial fat and its influence on cardiac diastolic function. Cardiovasc Diabetol. 2020 Aug 17;19(1):129. doi: 10.1186/s12933-020-01097-2.