Trial document





This trial has been registered retrospectively.
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  DRKS00000015

Trial Description

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Title

Phase Contrast Imaging used for a quantitative evaluation of myocardial contractility in left ventricular dilatation and for the detection of myocardial ischemia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Aim of the study is the evaluation of velocities of the heart muscle by a new MRI technique and to assess the value of these velocities for the diagnosis of heart disease. After examination of healthy volunteers, patients with different diseases of the heart muscle are examined in order to get new insights in myocardial function in the healthy and diseased left ventricle. Using this new methods we hope to detect heart diseases in an earlier stage.

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Brief Summary in Scientific Language

Aim of the study is the evaluation of myocardial velocities by a new MRI phase contrast imaging technique (Tissue phase mapping) with high temporal and spatial resolution. The value of these new parameters of myocardial function for the diagnosis of heart disease will be assessed. After examination of healthy volunteers, patients with left ventricular dilatation due to pressure- or volume overloading are examined in order to get new insights in the complexity of myocardial function in the healthy and diseased left ventricle. Using this new methods we hope to detect pathologies of myocardial function, for example in valvular disease, in the context of myocardial ischemia or remodelling after myocardial infarction in an earlier stage.
6/10 Amendment for further healthy controls, patients after heart transplantation, patients with left bundle branch block.

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Organizational Data

  •   DRKS00000015
  •   2008/09/05
  •   2008/08/05
  •   yes
  •   Approved
  •   340/04, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF001739  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   Diseases of the circulation system
  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   Evaluation of myocardial velocities in patients with LVEDD>55 mm:
    Patients with dilatative cardiomyopathy
  •   Evaluation of myocardial velocities in patients with LVEDD>55 mm:
    Patients with relevant mitral- oder aortic insufficiency
  •   Evaluation of myocardial velocities in patients with LVEDD>55 mm:
    patients with arterial hypertension or aortic stenosis
  •   Evaluation of myocardial velocities in patients with suspected CAD
  •   Evaluation of myocardial velocities in patients with acute myocardial infarction
  •   Evaluation of myocardial velocities in patients after heart transplantation
  •   evaluation of myocardial velocities in patients with Left bundle branch block
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Diagnostic
  •   Parallel
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Primary Outcome

Differences/changes of myocardial motion

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Secondary Outcome

in patients after HTX or CRT: changes of clinical parameters (NYHA classes etc.)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2005/02/15
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Part 1:
Patients with LVEDD>55 mm:
20 patients with dilatative cardiomyopathy
20 patients with relevant mitral- oder aortic insufficiency
20 patients with arterial hypertension or aortic stenosis
Part 2:
20 patients with suspected CAD
Part 3:
20 patients with acute myocardial infarction

Amendment:
1. 60 additional healthy volunteers
2. 20 patients with complete left bundle branch block without cardiac disease and normal LVEF
3. 50 patients mit with complete left bundle branch block, LVEF≤35%, LVEDD > 55 mm and heart failure (NYHA class ≥ II) with dilated cardiomyopathy before CRT
4. 80 patients after heart transplantation (also follow-up)

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Exclusion Criteria

Part 1:
CAD, contraindications against MRI
Part 2:
Contraindications against MRI, Gadolinium or Adenosin. Reduced left ventricular function, relevant valvular disease, left bundle branch block.
Part 3:
Contraindications against MRI, Gadolinium or Adenosin. Reduced left ventricular function, relevant valvular disease, left bundle branch block.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Str. 55
    • D-79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Dr. med.  Daniela  Föll 
    • Hugstetter Str. 55
    • D-79106  Freiburg
    • Germany
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    • Kardiologie und Angiologie I, Universitäts Herzzentrum freiburg
    • Ms.  Dr. med.  Daniela  Föll 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Universitätsklinikum Freiburg
    • D-79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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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.