Clinical trial NCT03074253: Cardiovascular Imaging and Biomarker Analyses (CIBER)
Official title: Cardiovascular Imaging and Biomarker Analyses (CIBER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Heart Diseases
Heart Failure
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac imaging (i.g. echocardiography, cardiac MRI, cardiac CT) within the clinical routine.

Brief summary: "Cardiovascular Imaging and Biomarker Analyses (CIBER)" is a single-center, prospective and observational study evaluating the expression of novel biomarkers in patients undergoing cardiacvascular imaging within clinical routine care. It is aimed to evaluate associations with biomarker expressions with ascertained cardiac imaging parameters.

Detailed description: "Cardiovascular Imaging and Biomarker Analyses (CIBER)" is a single-center, prospective and observational study evaluating the expression of novel biomarkers in patients undergoing cardiacvascular imaging within clinical routine care. It is aimed to evaluate associations with biomarker expressions with ascertained cardiac imaging parameters. Furthermore the prognostic value of biomarkers and imaging parameters on mid-term and long-term prognosis will be evaluated. Novel biomarkers will comprise blood derived biomarkers including neurohormones, proteins, cytokines, microRNAs and metabolomics.

Eligibility criteria: Inclusion Criteria:

* patients with low to intermediate risk for coronary artery disease

Exclusion Criteria:

* under 18 years
* mechanical heart valve
* pulmonary embolism
* deep vein thrombosis
* myocardial infarction within the last 3 months
* electrical cardioversion within 30 days
* status after heart transplant
* transient ischemic attack (TIA) or stroke within last 30 days
* intracerebral bleeding within the last 2 months
* acute infection
* existing or planned pregnancy
* chronic kidney disease with eGFR \< 40 ml/min

Primary outcomes:
measure: Biomarker levels before cardiac imaging
timeFrame: 24 hours before cardiac imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: First Department of Medicine, University Medical Centre Mannheim
Study officials:
affiliation: University Medical Center Mannheim
name: Ibrahim Akin, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Kim SH, Behnes M, Natale M, Hoffmann J, Reckord N, Hoffmann U, Budjan J, Henzler T, Papavassiliu T, Borggrefe M, Bertsch T, Akin I. Galectin-3 Reflects Mitral Annular Plane Systolic Excursion Being Assessed by Cardiovascular Magnetic Resonance Imaging. Dis Markers. 2016;2016:7402784. doi: 10.1155/2016/7402784. Epub 2016 Dec 1.
citation: Behnes M, Lang S, Breithardt OA, Kaden JJ, Haghi D, Ahmad-Nejad P, Elmas E, Wolpert C, Borggrefe M, Neumaier M, Brueckmann M. Association of NT-proBNP with severity of heart valve disease in a medical patient population presenting with acute dyspnea or peripheral edema. J Heart Valve Dis. 2008 Sep;17(5):557-65.
citation: Behnes M, Bertsch T, Weiss C, Ahmad-Nejad P, Akin I, Fastner C, El-Battrawy I, Lang S, Neumaier M, Borggrefe M, Hoffmann U. Triple head-to-head comparison of fibrotic biomarkers galectin-3, osteopontin and gremlin-1 for long-term prognosis in suspected and proven acute heart failure patients. Int J Cardiol. 2016 Jan 15;203:398-406. doi: 10.1016/j.ijcard.2015.10.127. Epub 2015 Oct 20.
citation: Behnes M, Brueckmann M, Lang S, Espeter F, Weiss C, Neumaier M, Ahmad-Nejad P, Borggrefe M, Hoffmann U. Diagnostic and prognostic value of osteopontin in patients with acute congestive heart failure. Eur J Heart Fail. 2013 Dec;15(12):1390-400. doi: 10.1093/eurjhf/hft112. Epub 2013 Jul 12.
citation: Ansari U, Behnes M, Hoffmann J, Weidner K, Kuche P, Rusnak J, Kim SH, Natale M, Reckord N, Lang S, Hoffmann U, Bertsch T, Fatar M, Borggrefe M, Akin I. Galectin-3 reflects the echocardiographic quantification of right ventricular failure. Scand Cardiovasc J. 2021 Dec;55(6):362-370. doi: 10.1080/14017431.2021.1995036. Epub 2021 Nov 5.
citation: Hoffmann J, Behnes M, Ansari U, Weidner K, Kuche P, Rusnak J, Kim SH, Natale M, Reckord N, Lang S, Hoffmann U, Bertsch T, Fatar M, Borggrefe M, Akin I. The association of high-sensitivity cardiac troponin I and T with echocardiographic stages of heart failure with preserved ejection fraction. Ann Clin Biochem. 2019 Jul;56(4):431-441. doi: 10.1177/0004563219841644. Epub 2019 May 21. No abstract available.
citation: Rusnak J, Behnes M, Henzler T, Reckord N, Vogler N, Meyer M, Hoffmann U, Natale M, Hoffmann J, Hamed S, Weidner K, Lang S, Mukherji A, Haubenreisser H, Schoenberg SO, Borggrefe M, Bertsch T, Akin I. Comparative analysis of high-sensitivity cardiac troponin I and T for their association with coronary computed tomography-assessed calcium scoring represented by the Agatston score. Eur J Med Res. 2017 Nov 16;22(1):47. doi: 10.1186/s40001-017-0290-9.
citation: Rusnak J, Behnes M, Reckord N, Hoffmann U, Natale M, Hoffmann J, Weidner K, Lang S, Mukherji A, Kruska M, Henzler T, Schoenberg SO, Borggrefe M, Bertsch T, Akin I. High Sensitivity Troponins Discriminate Different Morphologies of Coronary Artery Plaques Being Assessed by Coronary Computed Tomography Angiography. Dis Markers. 2017;2017:9306409. doi: 10.1155/2017/9306409. Epub 2017 Jul 18.