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Analysis of Human Coronary Aspirate (AHCA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Universität Duisburg-Essen.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Petra Kleinbongard, Universität Duisburg-Essen Identifier:
First received: August 24, 2011
Last updated: December 2, 2014
Last verified: December 2014
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.

Condition Intervention
Coronary Arteriosclerosis
Coronary Heart Disease
No Reflow Phenomenon
Other: Aspirated Coronary Blood

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction

Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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

Biospecimen Retention:   Samples With DNA
  • coronary arterial blood distal to the lesion before stent implantation
  • coronary aspirate blood during stent implantation

Estimated Enrollment: 500
Study Start Date: April 2004
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aspirate Blood 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.

Detailed Description:


  • 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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive, symptomatic patients with a significant stenosis in a native coronary vessel or a saphenous vein aortocoronary bypass graft.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01430884

Contact: Petra Kleinbongard, PhD +49-201-723-2763
Contact: Theodor Baars, MD +49-201-723-84812

Center of Internal Medicine, University of Essen Medical School Recruiting
Essen, Germany, 45122
Contact: Petra Kleinbongard, PhD    +49-201-723-2763   
Contact: Theodor Baars, MD    +49-723-84812   
Principal Investigator: Petra Kleinbongard, PhD         
Sub-Investigator: Heike Hildebrandt, MD         
Sponsors and Collaborators
Universität Duisburg-Essen
Principal Investigator: Petra Kleinbongard, PhD Institute of Pathophysiology, University of Essen Medical School
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Petra Kleinbongard, scientific assistant, Universität Duisburg-Essen Identifier: NCT01430884     History of Changes
Other Study ID Numbers: ASP-04
Study First Received: August 24, 2011
Last Updated: December 2, 2014

Keywords provided by Universität Duisburg-Essen:
coronary aspirate blood
particular debris / microemboli
distal occlusion device

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
No-Reflow Phenomenon
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Myocardial Infarction
Pathologic Processes processed this record on May 23, 2017