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
  Purpose

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

Resource links provided by NLM:


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 ] [ 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)


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 ] [ 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


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 2014
Estimated Primary Completion Date: March 2014 (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:

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.
  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430884

Contacts
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

Locations
Germany
Center of Internal Medicine, University of Essen Medical School Recruiting
Essen, Germany, 45122
Contact: Petra Kleinbongard, PhD    +49-201-723-2763    petra.kleinbongard@uk-essen.de   
Contact: Theodor Baars, MD    +49-723-84812    theodor.baars@uk-essen.de   
Principal Investigator: Petra Kleinbongard, PhD         
Sub-Investigator: Heike Hildebrandt, MD         
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Petra Kleinbongard, PhD Institute of Pathophysiology, University of Essen Medical School
  More Information

No publications provided by Universität Duisburg-Essen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Petra Kleinbongard, scientific assistant, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01430884     History of Changes
Other Study ID Numbers: ASP-04
Study First Received: August 24, 2011
Last Updated: September 20, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Atherosclerosis
No-Reflow Phenomenon
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Infarction
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014