Analysis of Human Coronary Aspirate (AHCA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Universität Duisburg-Essen
Sponsor:
Information provided by (Responsible Party):
Petra Kleinbongard, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01430884
First received: August 24, 2011
Last updated: September 20, 2013
Last verified: September 2013

August 24, 2011
September 20, 2013
April 2004
March 2014   (final data collection date for primary outcome measure)
Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential. [ Time Frame: up to two years ] [ Designated as safety issue: No ]
  • 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)
Characterisation of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential. [ Time Frame: up to two years ] [ Designated as safety issue: No ]
  • 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)
Complete list of historical versions of study NCT01430884 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    intra- individual comparison of all parameter for stenosis severity and plaque characterisation
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 ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
Analysis of Human Coronary Aspirate
Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction

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.

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 between 14 and 18 atm and a balloon-to-vessel diameter ratio of 1:1.

Coronary arterial blood and coronary aspirate

  • Coronary arterial blood is taken distal to the lesion before stent implantation and coronary aspirate blood is obtained during stent implantation (each in Heparin- or EDTA- Monovettes, SARSTEDT AG & Co, Nümbrecht, Germany).
  • Ex vivo coronary aspirate blood is filtered through a mesh filter with pores of 40 μm diameter.
  • Immediately centrifugation of the filtered coronary arterial and aspirate blood (800g, 10 min, 4°C).
  • Particulate debris and coronary arterial and aspirate plasma are quickly frozen in liquid nitrogen and stored at -80°C until further use.

Analysis / Aim :

  • Using different methods for determining severity of stenosis and plaque composition.
  • Using different biochemical methods to characterize particular and soluble substances released during stenting into coronary aspirate.
  • Using different bioassays to study vasoconstrictor potential of human coronary aspirate plasma and the impact. of coronary aspirate on the coronary microcirculation and on cardiac contraction.
  • Correlation of ex vivo measurements with patients disease and clinical symptoms.
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
  • coronary arterial blood distal to the lesion before stent implantation
  • coronary aspirate blood during stent implantation
Non-Probability Sample

Consecutive, symptomatic patients with a significant stenosis in a native coronary vessel or a saphenous vein aortocoronary bypass graft.

  • Coronary Arteriosclerosis
  • Coronary Heart Disease
  • No Reflow Phenomenon
Other: Aspirated Coronary Blood
Coronary arterial blood is taken distal to the lesion before stent implantation and serve as control and coronary aspirate blood is obtained during stent implantation.
Aspirate Blood
Intervention: Other: Aspirated Coronary Blood
Baars T, Konorza T, Kahlert P, Möhlenkamp S, Erbel R, Heusch G, Kleinbongard P. Coronary aspirate TNFα reflects saphenous vein bypass graft restenosis risk in diabetic patients. Cardiovasc Diabetol. 2013 Jan 10;12:12. doi: 10.1186/1475-2840-12-12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
November 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic patients with a significant stenosis (diameter stenosis >75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft

Exclusion Criteria:

  • Patients whereby a distal balloon occlusion devices is not applicable
Both
Not Provided
No
Contact: Petra Kleinbongard, PhD +49-201-723-2763 petra.kleinbongard@uk-essen.de
Contact: Theodor Baars, MD +49-201-723-84812 theodor.baars@uk-essen.de
Germany
 
NCT01430884
ASP-04
No
Petra Kleinbongard, Universität Duisburg-Essen
Universität Duisburg-Essen
Not Provided
Principal Investigator: Petra Kleinbongard, PhD Institute of Pathophysiology, University of Essen Medical School
Universität Duisburg-Essen
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP