Coronary ArteriosclerosisAHCANCT01430884
Analysis of Human Coronary Aspirate
An observational study of Coronary Arteriosclerosis and Coronary Heart Disease, run by Universität Duisburg-Essen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Arteriosclerosis, Coronary Heart Disease, No Reflow Phenomenon
- What is being tested?
- Aspirated Coronary Blood
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive, symptomatic patients with a significant stenosis in a native coronary vessel or a saphenous vein aortocoronary bypass graft.
Who may be able to join
- Symptomatic patients with a significant stenosis (diameter stenosis >75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft
Who cannot join
- Patients whereby a distal balloon occlusion devices is not applicable
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Center of Internal Medicine, University of Essen Medical School
Essen, 45122
Petra Kleinbongard, PhD, +49-201-723-2763, petra.kleinbongard@uk-essen.de
Theodor Baars, MD, +49-723-84812, theodor.baars@uk-essen.de
About this study
Official title: Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction
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.
Read the detailed 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:
- 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)
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.
- Being tested
- Aspirated Coronary Blood
- Keywords
- coronary aspirate blood, particular debris / microemboli, distal occlusion device
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirated Coronary BloodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aspirate Blood | Not described Receives: Other: Aspirated Coronary Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: up to three years
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
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startApr 2004
- Primary completionMar 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Kleinbongard, Universität Duisburg-Essen
- Investigators
- Petra Kleinbongard, PhD, Principal investigator, Institute of Pathophysiology, University of Essen Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430884
- Sponsor's protocol ID
- ASP-04
- Acronym
- AHCA
- Status last verified
- Dec 2014
- First submitted
- 24 Aug 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25915510Baars 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.
PubMed 23305356
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction
- ClinicalTrials.gov ID
- NCT01430884
- Acronym / sponsor ID
- AHCA / ASP-04
- Keywords
- coronary aspirate blood, particular debris / microemboli, distal occlusion device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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)
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspirate Blood | – | Other: Aspirated Coronary Blood |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive, symptomatic patients with a significant stenosis in a native coronary vessel or a saphenous vein aortocoronary bypass graft.
Key inclusion criteria (1 listed)
- Symptomatic patients with a significant stenosis (diameter stenosis >75% or significant FFR) in a native coronary vessel or a saphenous vein aortocoronary bypass graft
Key exclusion criteria (1 listed)
- Patients whereby a distal balloon occlusion devices is not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirated Coronary BloodCoronary arterial blood is taken distal to the lesion before stent implantation and serve as control and coronary aspirate blood is obtained during stent implantation. | Other | Aspirate Blood |
Primary outcome
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)
2 secondary outcomes
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
Comparison of stenosis severity estimation using QCA and FFR versus IVUS, OCT and NIRS
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 25915510Horn 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.
- Derived from this study: PubMed 23305356Baars 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Kleinbongard, PhD principal investigator
Institute of Pathophysiology, University of Essen Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis and Coronary Heart Disease, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Kleinbongard, PhD (+49-201-723-2763, petra.kleinbongard@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential. (time frame: up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01430884, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.