Trial document




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  DRKS00000791

Trial Description

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Title


Flow in Coronary Arteries -Wall Shear Stress as Coronary Risk.

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Trial Acronym

Non-invasive CFD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A novel approach to analysis of wall shear stress in coronary arteries based on patient specific data is supposed to improve the prediction of development of local and diffuse obstructions and aneurysms. Moreover, this approach allows simulation and planning of different interventions and is expected to improve tailoring of individual therapy. The necessary data on coronary flow and geometry are currently derived invasively. The study is intended to answer the question, whether a non-invasive approach by magnetic resonance imaging provides data with sufficient accuracy and resolution. Patients with indication for angiography are eligible. Selection is based on diagnosis of ischemia in stress magnetic resonance imaging. Patients are informed if ischemia is suspected and a contraindication for magnetic resonance imaging is lacking. Preliminary inclusion is based on the consent of patients. The extended magnetic resonance imaging protocol includes imaging of the right coronary artery, perfusion measurements and a flow-measurement in the proximal right coronary artery. Patients are definitely included if stress magnetic resonance imaging supports the diagnosis of ischemia and adequate imaging and flow-measurements are available. Additional investigations during angiography are intracoronary velocity and pressure measurements and wall imaging in the ight coronary artery.
A diagnostic non-invasive MRI after one year is the touchstone to probe the risk prediction model.

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Brief Summary in Scientific Language

A novel non-dimensional approach to analysis of wall shear stress in coronary arteries based on patient specific data is supposed to improve the prediction of luminal remodeling. Recent results on controllability of complex systems
suggest that identification of "critical nodes" is of paramount importance. Modeling combined with simulation is expected to improve planning of complex interventions and to improve tailoring of individual therapy. The necessary data on coronary flow and geometry are currently derived invasively. The study is intended to answer the question, whether a non-invasive approach by magnetic resonance imaging provides data with sufficient accuracy and resolution. Patients with indication for angiography are eligible. Selection is based on diagnosis of ischemia in stress magnetic resonance imaging. Patients are informed if ischemia is suspected and a contraindication for magnetic resonance imaging is lacking. Preliminary inclusion is based on the consent of patients. The extended magnetic resonance imaging protocol includes imaging of the right coronary artery, perfusion measurements and a flow-measurement in the proximal right coronary artery. Patients are definitely included if stress magnetic resonance imaging supports the diagnosis of ischemia and adequate imaging and flow-measurements are available. Additional investigations during angiography are intracoronary velocity and pressure measurements and wall imaging by intravascular ultrasound or optical coherence tomography in the right coronary artery.
A diagnostic non-invasive MRI after one year is the touchstone to probe the risk prediction model.

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Organizational Data

  •   DRKS00000791
  •   2011/12/05
  •   [---]*
  •   yes
  •   Approved
  •   EA2/077/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1122-0268 
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Health Condition or Problem studied

  •   Coronary artery disease
  •   I25 -  Chronic ischaemic heart disease
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Interventions/Observational Groups

  •   A MRI will be done in patients with suspected ischemia. In case of a positive test confirming ischemia the patient will be included and a cardiac catheterization will be performed with the option of a percutaneous coronary intervention (PCI), if indicated. A follow-up MRI will be performed after 1 year in study patients.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Agreement of predicted group adherence (negative, expansive normal remodeling) between MRI based and catheterization- based diagnostic flow simulation studies.

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Secondary Outcome

1) Comparison of anatomical data and flow data for the right coronary artery between magnetic resonance imaging and catheterization-based data acquisition and of wall shear stress calculations based on flow-simulations using catheterization based data and MRI derived data.
2) Exploratory investigations regarding the impact of changes in wall shear stress and derived parameters on events during follow-up and findings in magnetic resonance imaging after one year. Important goal is the collection of data for planning future investigations of coronary flow as risk factor in coronary arteries.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/11/17
  •   77
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   no maximum age
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Additional Inclusion Criteria

Adult patients with clinically suspected ischemia and diagnostic magnetic resonance imaging

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Exclusion Criteria

Contraindications against magnetic resonance imaging
Relative contraindications against catheterization and intracoronary imaging.

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Addresses

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    • Deutsches Herzzentrum Berlin
    • Mr.  Priv. Doz. Dr. med.  Ernst  Wellnhofer 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
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    • Deutsches Herzzentrum Berlin
    • Mr.  Priv. Doz. Dr. med.  Ernst  Wellnhofer 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Deutsches Herzzentrum Berlin
    • Mr.  Priv. Doz. Dr. med.  Ernst  Wellnhofer 
    • Augustenburger Pl.1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Herzzentrum Berlin
    • Mr.  Prof. Dr. med.  Eckart  Fleck 
    • Augustenburger Pl.1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.