Analysis of Human Coronary Aspirate

NCT01430884 | Unknown

• 1 other identifier: ASP-04
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Arteriosclerosis; Coronary Heart Disease; No Reflow Phenomenon

Keywords

coronary aspirate blood; particular debris / microemboli; distal occlusion device

Outcome Measures

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)

  up to two years

Secondary Outcomes (2)

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

  up to three years

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

  up to one year

Study Arms (1)

Aspirate Blood

Other: Aspirated Coronary Blood

Interventions

Aspirated Coronary Blood OTHER

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.

Aspirate Blood

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Symptomatic patients with a significant stenosis (diameter stenosis \>75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft

You may not qualify if:

• Patients whereby a distal balloon occlusion devices is not applicable

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Center of Internal Medicine, University of Essen Medical School

Essen, 45122, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 25915510 DERIVED

• 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.

  PMID: 23305356 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* coronary arterial blood distal to the lesion before stent implantation * coronary aspirate blood during stent implantation

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; No-Reflow Phenomenon

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Petra Kleinbongard, PhD

  Institute of Pathophysiology, University of Essen Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Kleinbongard, PhD

CONTACT

+49-201-723-2763; petra.kleinbongard@uk-essen.de

Theodor Baars, MD

CONTACT

+49-201-723-84812; theodor.baars@uk-essen.de

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: scientific assistant

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: September 8, 2011
• Study Start: April 1, 2004
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DE (1)