Analysis of Human Coronary Aspirate

Coronary Heart Disease Clinical Trial

— AHCA  

Official title:

Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01430884
• Other study ID #: ASP-04
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2011
• Last updated: December 2, 2014
• Start date: April 2004
• Est. completion date: November 2015

Study information

• Verified date: December 2014
• Source: Universität Duisburg-Essen
• Contact: Petra Kleinbongard, PhD
• Phone: +49-201-723-2763
• Email: petra.kleinbongard[@]uk-essen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• No Reflow Phenomenon
• No-Reflow Phenomenon

Intervention

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.

Locations

Country	Name	City	State
Germany	Center of Internal Medicine, University of Essen Medical School	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to two years	No
Secondary	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	up to three years	No
Secondary	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	up to one year	No