Trial document





This trial has been registered retrospectively.
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  DRKS00009293

Trial Description

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Title

Evaluation of the alteration of spiroergometric parameters for CAD-patients after recanalization of chronic occluded coronary arteries (CTO)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To ensure the method of CTO (recanalization of chronic occluded coronary arteries) with scientific data, we plan to do a spiroergometry with all the patients we would recommend having a CTO. The spiroergometry is a non-invasive exercise test which is supposed to take place right before and 6 months after CTO.
We compare certain parameters of circulation, that tell us something about the uptake and utilization of oxygen in the human body.

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Brief Summary in Scientific Language

This study is supposed to prove the efficiancy of CTO (recanalization of chronic occluded coronary arteries)-procedures in matters of the physiologic performance parameters on the basis of the oxygen uptake in spiroergometry.
Therefore we plan a spiroergometric examination right before CTO (T0) and 6 months after the last revascularization with measurement and comparison of the maximum performance, the VO2max, VO2 at the anaerobic barrier and the for O2 and CO2 ventilatory equivalent.

On the one hand we want to prove, that patients can grow on their cardiopulmonal efficiency after successful revascularization of a chronical total occlusion. On the other hand we witnessed in the past, that patients with absent improvement in performance often had a in-stent-occlusion or a highly de-novo stenosis.
By this we are able to facilitate the indication for a reangiography.
Further we might ensure patients without explicit angina after successful recanalization an improvement of the cardiopulmonal performance parameters.
We would like to contrast the risks, costs and stress of a CTO with the patient’s benefit.
By a comparison of boundary conditions we try to select between more and less appropriate patients.

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Organizational Data

  •   DRKS00009293
  •   2015/10/02
  •   [---]*
  •   yes
  •   Approved
  •   EK-BR-20/15-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Chronic Total coronary occlusions
  •   I25.11 -  [generalization I25.1: Atherosclerotic heart disease]
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Interventions/Observational Groups

  •   This study is supposed to prove the efficiancy of CTO (recanalization of chronic occluded coronary arteries)-procedures in matters of the physiologic performance parameters on the basis of the oxygen uptake in spiroergometry.
    Therefore we plan a spiroergometric examination right before CTO (T0) and 6 months after the last revascularization with measurement and comparison of the maximum performance, the VO2max, VO2 at the anaerobic barrier and the for O2 and CO2 ventilatory equivalent.

    On the one hand we want to prove, that patients can grow on their cardiopulmonal efficiency after successful revascularization of a chronical total occlusion. On the other hand we witnessed in the past, that patients with absent improvement in performance often had a in-stent-occlusion or a highly de-novo stenosis.
    By this we are able to facilitate the indication for a reangiography.
    Further we might ensure patients without explicit angina after successful recanalization an improvement of the cardiopulmonal performance parameters.
    We would like to contrast the risks, costs and stress of a CTO with the patient’s benefit.
    By a comparison of boundary conditions we try to select between more and less appropriate patients.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Measurement of the maximum oxygen uptake during spiroergometry 6 months after CTO

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/10/17
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

-diagnosis: atherosclerotic hearts disease with one ore more Chronic Total coronary occlusions
-demonstration of a chronic occluded main vessel with clinical symptoms (angina pectoris, dyspnoea, cardiac insufficiency) independent from severity and length of disease
- proof of vitality of the less perfused supply zone of the myocardium
- for our study we only recruit patient with successful coronary vessel recanalization

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Exclusion Criteria

- refusal of the spiroergometry for several reasons (pre-existing orthopedic, pulmonic, neurologic diseases) that make an adequate stress impossible
- expected incompliance due to the target stress level, the optimum medical therapy or fulfilment of medical appointments
- additional coronary interventions during the observation period
-malignant diseases and other accompanying diseases which might lead to a reduced physical resilience for other reasons
- participation in another clinical trial
- all patients who did not get an optimum medical therapy
- patient with newly-discovered severe diseases
- severe vitiums
- pregnancy or lactation
- existing addictive disorders

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Addresses

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    • Helios ForschungszentrumHelios Research Center GmbH Berlin Deutschland
    • Wiltbergstraße 50
    • 13125  Berlin
    • Germany
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    • HELIOS Vogtland Klinikum
    • Mr.  OA Dr. med. univ.  Kambis  Mashayekhi 
    • Röntgentraße 2
    • 08529  Plauen
    • Germany
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    • HELIOS Vogtland Klinikum
    • Mr.  OA Dr. med. univ.  Kambis  Mashayekhi 
    • Röntgenstraße 2
    • 08529  Plauen
    • Germany
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Sources of Monetary or Material Support

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    • Helios ForschungszentrumHelios Research Center GmbH Berlin Deutschland
    • Wiltbergstraße 50
    • 13125  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/30
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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.