Cardiovascular Imaging and Biomarker Analyses (CIBER)

Coronary Artery Disease Clinical Trial

— CIBER  

Official title:

Cardiovascular Imaging and Biomarker Analyses (CIBER)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03074253
• Other study ID #: 2014-615N-MA
• Status: Active, not recruiting
• Start date: December 1, 2014
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2019
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Failure

Intervention

Diagnostic Test:
• Echocardiography
Patients are undergoing echocardiography
• magnetic resonance imaging
Patients are undergoing magnetic resonance imaging
• computed tomography
Patients are undergoing computed tomography
• blood withdrawl
Peripheral blood samples are being collected from all patients

Locations

Country	Name	City	State
Germany	First Department of Medicine, University Medical Centre Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker levels before cardiac imaging		24 hours before cardiac imaging