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Status unknownNCT01430884AHCAUpdated Dec 3, 2014

Analysis of Human Coronary Aspirate

An observational study in Coronary Arteriosclerosis, Coronary Heart Disease and No Reflow Phenomenon, sponsored by Universität Duisburg-Essen. Status unknown at 1 site in Germany. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by Universität Duisburg-Essen · Observational

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Cross-sectional
Enrollment
500
Sex
All
01

Study 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.

Read the detailed description

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.
02

Conditions studied

  • Coronary Arteriosclerosis
  • Coronary Heart Disease
  • No Reflow Phenomenon

Keywords

  • coronary aspirate blood
  • particular debris / microemboli
  • distal occlusion device
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 500 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Universität Duisburg-Essen is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Patients whereby a distal balloon occlusion devices is not applicable
05

Study design

Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Aspirate Blood

    Other: Aspirated Coronary Blood

Interventions

  • OtherAspirated 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.

06

What researchers measure

Primary outcomes

  1. Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential.

    * 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)

    Time frame: up to two years

Secondary outcomes

  1. Correlation of characteristics of soluble and particular substances within aspirate to characteristics of coronary lesion and/or patients underlying disease

    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

    Time frame: up to three years

  2. Comparison of stenosis severity estimation using QCA and FFR versus IVUS, OCT and NIRS

    intra- individual comparison of all parameter for stenosis severity and plaque characterisation

    Time frame: up to one year

07

Study locations

1 of 1 sites recruiting
  • Center of Internal Medicine, University of Essen Medical School
    Essen, 45122, Germany
    Recruiting
08

References and documents

Publications

  • Horn P, Baars T, Kahlert P, Heiss C, Westenfeld R, Kelm M, Erbel R, Heusch G, Kleinbongard P. Release of Intracoronary Microparticles during Stent Implantation into Stable Atherosclerotic Lesions under Protection with an Aspiration Device. PLoS One. 2015 Apr 27;10(4):e0124904. doi: 10.1371/journal.pone.0124904. eCollection 2015. PubMed 25915510 ↗
  • Baars T, Konorza T, Kahlert P, Mohlenkamp S, Erbel R, Heusch G, Kleinbongard P. Coronary aspirate TNFalpha reflects saphenous vein bypass graft restenosis risk in diabetic patients. Cardiovasc Diabetol. 2013 Jan 10;12:12. doi: 10.1186/1475-2840-12-12. PubMed 23305356 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01430884
Lead sponsor
Universität Duisburg-Essen
Responsible party
Petra Kleinbongard (scientific assistant, Universität Duisburg-Essen) — Principal investigator
First posted
Sep 8, 2011
Start date
Apr 2004
Primary completion
Mar 2015 (estimated)
Completion
Nov 2015 (estimated)
Last update
Dec 3, 2014

Study contacts

Petra Kleinbongard, PhD
Contact
petra.kleinbongard@uk-essen.de
+49-201-723-2763
Theodor Baars, MD
Contact
theodor.baars@uk-essen.de
+49-201-723-84812
Petra Kleinbongard, PhD
principal investigator · Institute of Pathophysiology, University of Essen Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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