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Status unknownNCT03074253CIBERUpdated Oct 31, 2019

Cardiovascular Imaging and Biomarker Analyses (CIBER)

An observational study in Coronary Artery Disease, Heart Diseases and Heart Failure, sponsored by Universitätsmedizin Mannheim. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-31.

Sponsored by Universitätsmedizin Mannheim · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Coronary Artery Disease
  • Heart Diseases
  • Heart Failure
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In context

Coronary Artery Disease

5,677 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 500 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with low to intermediate risk for coronary artery disease

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testEchocardiography

    Patients are undergoing echocardiography

  • Diagnostic testmagnetic resonance imaging

    Patients are undergoing magnetic resonance imaging

    Also known as: MRI

  • Diagnostic testcomputed tomography

    Patients are undergoing computed tomography

    Also known as: CT

  • Diagnostic testblood withdrawl

    Peripheral blood samples are being collected from all patients

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What researchers measure

Primary outcomes

  1. Biomarker levels before cardiac imaging

    Time frame: 24 hours before cardiac imaging

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Study locations

1 site
  • First Department of Medicine, University Medical Centre Mannheim
    Mannheim, 68167, Germany
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References and documents

Publications

  • 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. PubMed 28044067 ↗
  • 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. PubMed 18980090 ↗
  • 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. PubMed 26539964 ↗
  • 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. PubMed 23851388 ↗
  • 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. PubMed 34738853 ↗
  • 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. PubMed 31112389 ↗
  • 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. PubMed 29145895 ↗
  • 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. PubMed 28804199 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2014 (actual). Primary completion is estimated for Jul 2020, 67 months after the start.

Of 726 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 67 months is above that.

Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2017
First posted
Mar 8, 2017
StartActual
Dec 1, 2014
Primary completionEst.
Jul 1, 2020
CompletionEst.
Jul 1, 2021
Last update
Oct 31, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03074253
Lead sponsor
Universitätsmedizin Mannheim
Responsible party
Michael Behnes (Dr. med, Universitätsmedizin Mannheim) — Principal investigator
First posted
Mar 8, 2017
Start date
Dec 1, 2014
Primary completion
Jul 1, 2020 (estimated)
Completion
Jul 1, 2021 (estimated)
Last update
Oct 31, 2019

Study contacts

Ibrahim Akin, Prof. Dr.
study director · University Medical Center Mannheim

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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