Trial document




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  DRKS00009435

Trial Description

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Title

Analysis of extracellular vesicles and circulating microRNAs in remote ischemic preconditioning of coronary artery disease patients

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Trial Acronym

ExoRIP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Coronary artery bypass graft surgery (CABG) may lead to under-supply of the myocardium with vital oxygen. resulting in a significantly reduced quality of life. In the "Remote preconditioning" a short-lasting oxygen deficiency against ischemia-rugged parts of the body such as the forearm or lower leg is produced by inflating a blood pressure cuff. This messengers are in this part of the body apparently released or processes set in motion, then increase the durability of vital organs such as brain and heart - if it should then come to a surgically induced oxygen deficiency. This remote ischemic conditioning so makes the body's own protective substances for Use, which are transported through the blood vessels to the damaged heart and can therefore, in the case of ischemia, such as occurs for example in a CABG surgery to limit the damage. It begs the question, kardioproteiktive substances whether small particles (so-called. Exosomes) (so-called. MicroRNAs) transport to the heart there to initiate a protective effect

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Brief Summary in Scientific Language

Promising observations have already been listed for methods of remote conditioning during clinical studies. It was, however, not yet exactly clear in what way cardioprotective signals between organs are mediated. Humoral and endocrine aspects and mediators are discussed. In addition, vesicular transfer mechanisms, so-called extracellular vesicles, which also belong to the exosomes, for the Inter-organ communication in question. Come Exosomes are membrane bound structures, which are secreted by a variety of mammalian cell types via distinct mechanisms. Since exosomes contain a high concentration of RNA and proteins and both actively secreted as are received by other cells, they represent obviously an important intercellular signaling mechanism. Based on these published data, however, two important questions arise: Does ischemic remote conditioning a significant release of circulating exosomes from the ischemic limb at a concentration above the physiological concentration of 1 x 1010 per mL or if the cardioprotective effect rather a change in the internal composition of the exosomal components of the ischemic limb is based? These questions are so far insufficient data.

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Organizational Data

  •   DRKS00009435
  •   2015/10/01
  •   [---]*
  •   yes
  •   Approved
  •   14-5803-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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

  •   I25.1 -  Atherosclerotic heart disease
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Interventions/Observational Groups

  •   Placebo: given the standard therapy, so no preconditioning, applying the blood pressure cuff but no pumping up the cuff
  •   RIPC: gets preoperatively as part of the induction of anesthesia ischemic preconditioning by a blood pressure cuff is inflated on the upper arm at 200 mmHg five minutes each in four cycles, after which each followed by a five-minute reperfusion.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Placebo
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

maximal postoperative troponin I increase within 7 days after coronary artery bypass surgery postoperatively

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/01/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Coronary heart disease
• CABG surgery with cardiopulmonary bypass
• ages 45 to 85 years
• Antegrade Bretschneider cardioplegia
• Mild hypothermia (32C °)
• Preoperative standard medication (statins, beta-blockers, aspirin)
• Standard anesthesia (isoflurane, sufentanil)
• Intraoperative standard protocol (full heparinization with ACT> 400s, aprotinin, protamine)
• Postoperative standard protocol (500mg aspirin after 2 hours, Low-dose heparinization after 4h)

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Exclusion Criteria

Condition after acute myocardial infarction
• combined valvular
• Emergency operation
• catecholamine
• Unstable angina
• IABP mounting
• pre- / intraoperative use of phosphodiesterase inhibitors
• Diabetes mellitus
• reoperation
• COPD GOLD III and IV
• renal insufficiency with creatinine> 1.5 mg / dl
Dual antithrombotic therapy (clopidogrel + aspirin)

Repeated cardiopulmonary bypass
• Repeated cross clamping of the aorta
• Intraoperative complications (bypass "low-flow" / -lock, frustrane valve reconstruction, Klappenausriss, aortic dissection, pump failure, implantation of cardiac assist systems)
• aortic cross clamping> 150 min
• Moderate / deep hypothermia (<32C °)
• Antithrombotic therapy (intraoperatively clopidogrel u. / O. Aspirin)
• Retrograde cardioplegia delivery

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Addresses

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    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Ulrich  Frey 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
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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.