Trial document




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  DRKS00014907

Trial Description

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Title

The RAMBO (RAdiation exposure in Monoplane versus Biplane cOronary interventions) Study

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Trial Acronym

RAMBO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

During coronary catheterization coronary vessels are depicted by X-radiation and the injection of contrast medium into the vessel. These images can be produced using two different techniques of the catheterization system, the monoplane and the biplane mode. Using the monoplane mode the coronary vessels are depicted in one plane (so-called "projection") with each injection of contrast medium, while with the biplane mode images can be gained simultaneously in two projections. Both techniques are perfectly suitable for imaging of the coronary vessels, but it is still unknown whether these techniques differ in terms of the patient's and investigator's radiation exposure. In the RAMBO Study we therefore want to detect the patient's and investigator's radiation exposure with radiation measurement devices during each coronary catheterization. Patients requiring coronary catheterization for suspected coronary artery disease are randomly assigned to monoplane (group I) or biplane (group II) imaging.

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Brief Summary in Scientific Language

The aim of the present trial is to compare the radiation exposure between monoplane and biplane coronary angiography. Patients requiring coronary catheterization for suspected coronary artery disease are randomly assigned to coronary angiography performed with either monoplane (Group 1) or biplane (Group 2) angiographic imaging. The primary endpoint of the trial is the radiation dose as measured at the investigator’s left arm. Secondary endpoints include investigator’s radiation exposure at the chest, the head as well as the patient’s radiation exposure, contrast volume and the procedural time.

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Organizational Data

  •   DRKS00014907
  •   2018/08/02
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  •   yes
  •   Approved
  •   EA1/109/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   Coronary angiography using monoplane imaging following the current guidelines and recommendations. The investigator wears dosimeters at the arm, the chest and the head. One dosimeter is placed next to the patient's chest.
  •   Coronary angiography using biplane imaging following the current guidelines and recommendations. The investigator wears dosimeters at the arm, the chest and the head. One dosimeter is placed next to the patient's chest.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1. Radiation dose detected at the investigator’s left arm (μSv)

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Secondary Outcome

2. Radiation dose detected at the investigator’s head (μSv)
3. Radiation dose detected at the investigator’s chest (μSv)
4. Fluoroscopy time (min)
5. Procedural time (min)
6. Contrast volume (ml)
7. Dose area product (Gy·cm²)
8. Radiation dose measured next to the patient’s thorax (μSv)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/08/03
  •   430
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

1. Male or female non-pregnant
2. Age ≥ 18 years and ≤ 85 years
3. Clinical indication for coronary catheterization and unknown coronary status
4. Written informed consent

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Exclusion Criteria

1. Emergency coronary catheterization
2. Coronary angiography of coronary artery bypass grafts
3. Renal insufficiency with creatinine clearance ≤45 ml/min
4. Hemodynamic instability
5. Psychiatric disorders in need of therapy
6. Refused participation

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Addresses

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    • Medizinische Klinik für Kardiologie - Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
    • Mr.  PD Dr. med.  David Manuel  Leistner 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Medizinische Klinik für Kardiologie - Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
    • Ms.  PD Dr. med., MBA  Barbara Elisabeth  Stähli 
    • Hindenburgdamm 30
    • Berlin
    • Germany
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    • Medizinische Klinik für Kardiologie - Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
    • Mr.  PD Dr. med.  David Manuel  Leistner 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Medizinische Klinik für KardiologieCharité - Universitätsmedizin Berlin - Campus Benjamin Franklin
    • Mr.  PD Dr. med.  David Manuel  Leistner 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Kardiologie, Campus Benjamin Franklin der Charité Universitätsmedizin Berlin
    • 12203  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/04/12
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Trial Publications, Results and other Documents

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