Analysis of Human Coronary Aspirate (AHCA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|