Analysis of Human Coronary Aspirate (AHCA)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 24, 2011 | ||||||||
| Last Updated Date | September 7, 2011 | ||||||||
| Start Date ICMJE | April 2004 | ||||||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Characterisation of particular and soluble substances released during stenting into coronary aspirate and its vasoconstrictor potential. [ Time Frame: up to two years ] [ Designated as safety issue: No ]
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01430884 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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 |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Analysis of Human Coronary Aspirate | ||||||||
| Official Title ICMJE | Human Coronary Aspirate: Characterization of Particular and Soluble Substances and the Impact on Microvascular Obstruction | ||||||||
| 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. |
||||||||
| Detailed Description | Patients
Stenosis severity/Plaque composition
Interventional procedure Distal balloon occlusion devices:
Coronary arterial blood and coronary aspirate
Analysis / Aim :
|
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
|
||||||||
| 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. |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | 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. |
||||||||
| Study Group/Cohort (s) | Aspirate Blood
Intervention: Other: Aspirated Coronary Blood |
||||||||
| Publications * | Baars T, Konorza T, Kahlert P, Möhlenkamp S, Erbel R, Heusch G, Kleinbongard P. Coronary aspirate TNFα reflects saphenous vein bypass graft restenosis risk in diabetic patients. Cardiovasc Diabetol. 2013 Jan 10;12:12. doi: 10.1186/1475-2840-12-12. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | November 2014 | ||||||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01430884 | ||||||||
| Other Study ID Numbers ICMJE | ASP-04 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Petra Kleinbongard, Universität Duisburg-Essen | ||||||||
| Study Sponsor ICMJE | Universität Duisburg-Essen | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Universität Duisburg-Essen | ||||||||
| Verification Date | September 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||