NCT03074253

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

5.6 years

First QC Date

March 3, 2017

Last Update Submit

October 30, 2019

Conditions

Coronary Artery DiseaseHeart DiseasesHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Biomarker levels before cardiac imaging

    24 hours before cardiac imaging

Interventions

EchocardiographyDIAGNOSTIC_TEST

Patients are undergoing echocardiography

magnetic resonance imagingDIAGNOSTIC_TEST

Patients are undergoing magnetic resonance imaging

Also known as: MRI
computed tomographyDIAGNOSTIC_TEST

Patients are undergoing computed tomography

Also known as: CT
blood withdrawlDIAGNOSTIC_TEST

Peripheral blood samples are being collected from all patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cardiac imaging (i.g. echocardiography, cardiac MRI, cardiac CT) within the clinical routine.

You may qualify if:

  • patients with low to intermediate risk for coronary artery disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Medicine, University Medical Centre Mannheim

Mannheim, 68167, Germany

Location

Related Publications (8)

  • 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.

    PMID: 28044067BACKGROUND

  • 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.

    PMID: 18980090BACKGROUND

  • 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.

    PMID: 26539964BACKGROUND

  • 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.

    PMID: 23851388BACKGROUND

  • 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.

    PMID: 34738853DERIVED

  • 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.

    PMID: 31112389DERIVED

  • 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.

    PMID: 29145895DERIVED

  • 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.

    PMID: 28804199DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

One peripheral blood withdraws in EDTA, citrate, ammonium heparin, serum tubes within 24 hours before cardiac imaging.

MeSH Terms

Conditions

Coronary Artery DiseaseHeart DiseasesHeart Failure

Interventions

EchocardiographyMagnetic Resonance ImagingTomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularTomographyImage Interpretation, Computer-AssistedRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-Ray

Study Officials

  • Ibrahim Akin, Prof. Dr.

    University Medical Center Mannheim

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 8, 2017

Study Start

December 1, 2014

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)