Clinical Trial: Analysis of Human Coronary Aspirate

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction

Brief Summary: During elective percutaneous coronary intervention (PCI), both proximal and distal protection devices are used. The distal occlusion protection device temporarily occludes the vessel distal to the lesion during the intervention, thereby capturing both particular debris and soluble substances released from the lesion such that they can be aspirated and prevented from reaching the coronary microcirculation. Rather than simply discarding the material which is retrieved from use of protection devices, the investigators have recently taken advantage of this situation, sampled the particulate and soluble material and subjected it to a variety of analyses with the ultimate goal to have a better insight into the respective plaque composition and to correlate it to the individual imaging and clinical data. On the basis of such information the investigators aim to better understand the pathophysiology of plaque vulnerability and to possibly predict the clinical development of the individual patient.

Detailed Summary:

Patients

  • Symptomatic patients with a significant stenosis (diameter stenosis >75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft.
  • All patients are on aspirin (100 mg/day) and received 10,000 I.U. heparin intravenously.
  • Coronary angiography is performed via the femoral approach.
  • Full informed consent are obtained from all patients before participating in the study.

Stenosis severity/Plaque composition

  • Quantification of stenosis severity was performed with the use of off-line caliper measurements (QCA-MEDIS, Leiden, NL).

  • Intravascular imaging analyses before and after stent implantation to characterize plaque morphology:

    1. IVUS(Eagle-EyeTM 20 MHz catheter and R-100 pullback device, Volcano Corporation, Rancho Cordova, CA, USA)
    2. OCT (St. Jude Medical Lightlab C7 Dragonfly Imaging Catheter)
    3. NIRS (InfraReDx TVC Insight catheter)

Interventional procedure

Distal balloon occlusion devices:

  • TriAktiv SVG/3.5-FX-catheter; Kensey Nash, Exton, USA or
  • GuardWire Temporary Occlusion & Aspiration System; Medtronic Inc., Minneapolis, MN USA Implantation of balloon-expandable stents using balloon pressures b
    Sponsor: Universität Duisburg-Essen

    Current Primary Outcome: Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential. [ Time Frame: up to two years ]

    • biochemical characterization: (quantification (as amount or concentration) of vasoconstrictive substances; cell fragments, proteins and lipids within the aspirate via HPLC, MS, or EIA Kits)
    • in vitro vasoconstriction, coronary microcirculation and cardiac contraction by aspirate (vasoconstriction detected as response of isolated arteries to aspirate normalized to that by KCl in a myograph; coronary microcirculation detected as coronary flow and cardiac contraction as left ventricular pressure within in the in vitro Langendorff heart model)


    Original Primary Outcome: Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential. [ Time Frame: up to two years ]

    • biochemical characterisation: (quantification (as amount or concentration) of vasoconstrictive substances; cell fragments, proteins and lipids within the aspirat via HPLC, MS, or EIA Kits)
    • in vitro vasoconstriction, coronary microcirculation and cardiac contraction by aspirate (vasoconstriction detected as response of isolated arteries to aspirate normalized to that by KCl in a myograph; coronary microcirculation detected as coronary flow and cardiac contraction as left ventricular pressure within in the in vitro langendorff-heart modell)


    Current Secondary Outcome:

    • Correlation of characteristics of soluble and particular substances within aspirate to characteristics of coronary lesion and/or patients underlying disease [ Time Frame: up to three years ]
      e.g.: concentration of vasoconstrictors to plaque composition; concentration of vasoconstrictors to patient underlying disease; amount of particular debris to plaque composition; amount of particular debris to patient underlying disease
    • Comparison of stenosis severity estimation using QCA and FFR versus IVUS, OCT and NIRS [ Time Frame: up to one year ]
      intra- individual comparison of all parameter for stenosis severity and plaque characterisation


    Original Secondary Outcome: Correlation of characteristics of soluble and particular substances within aspirate to characteristics of coronary lesion and/or patients underlying disease [ Time Frame: up to three years ]

    e.g.: concentration of vasoconstrictors to plaque composition; concentration of vasoconstrictors to patient underlying disease; amount of particular debris to plaque composition; amount of particular debris to patient underlying disease


    Information By: Universität Duisburg-Essen

    Dates:
    Date Received: August 24, 2011
    Date Started: April 2004
    Date Completion: November 2015
    Last Updated: December 2, 2014
    Last Verified: December 2014