Analysis of Human Coronary Aspirate (AHCA)
|ClinicalTrials.gov Identifier: NCT01430884|
Recruitment Status : Unknown
Verified December 2014 by Petra Kleinbongard, Universität Duisburg-Essen.
Recruitment status was: Recruiting
First Posted : September 8, 2011
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment|
|Coronary Arteriosclerosis Coronary Heart Disease No Reflow Phenomenon||Other: Aspirated Coronary Blood|
- 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:
- IVUS(Eagle-EyeTM 20 MHz catheter and R-100 pullback device, Volcano Corporation, Rancho Cordova, CA, USA)
- OCT (St. Jude Medical Lightlab C7 Dragonfly Imaging Catheter)
- NIRS (InfraReDx TVC Insight catheter)
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction|
|Study Start Date :||April 2004|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||November 2015|
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.
- 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)
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430884
|Contact: Petra Kleinbongard, PhDemail@example.com|
|Contact: Theodor Baars, MDfirstname.lastname@example.org|
|Center of Internal Medicine, University of Essen Medical School||Recruiting|
|Essen, Germany, 45122|
|Contact: Petra Kleinbongard, PhD +49-201-723-2763 email@example.com|
|Contact: Theodor Baars, MD +49-723-84812 firstname.lastname@example.org|
|Principal Investigator: Petra Kleinbongard, PhD|
|Sub-Investigator: Heike Hildebrandt, MD|
|Principal Investigator:||Petra Kleinbongard, PhD||Institute of Pathophysiology, University of Essen Medical School|