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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.
Patients
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:
Interventional procedure
Distal balloon occlusion devices:
Coronary arterial blood and coronary aspirate
Analysis / Aim :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirate Blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential. |
| up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive, symptomatic patients with a significant stenosis in a native coronary vessel or a saphenous vein aortocoronary bypass graft.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Petra Kleinbongard, PhD | Institute of Pathophysiology, University of Essen Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Internal Medicine, University of Essen Medical School | Recruiting | Essen | 45122 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25915510 | Derived | 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. | |
| 23305356 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D054318 | No-Reflow Phenomenon |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| 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 |
| 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. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |