Detection of coronary microembolization by Doppler ultrasound in patients with stable angina pectoris during percutaneous coronary interventions under an adjunctive antithrombotic therapy with abciximab: design and rationale of the High Intensity Transient Signals ReoPro (HITS-RP) study

Cardiovascular Ultrasound

Hypothesis

Daniel Kretzschmar¹  Hans R Figulla¹  Christian Jung¹  Stephan Utschig¹  Markus Ferrari¹  Sylvia Otto¹  Atilla Yilmaz¹  Tudor C Pörner¹  Thomas Lehmann²  Michael Hartmann³ 

[1] Department of Internal Medicine I, Division of Cardiology, University Hospital Jena, D-07740, Erlanger Allee 101, Jena, Germany;Institute of Medical Statistics, Computer Sciences and Documentation, University Hospital Jena, D-07743, Bachstraße 18, Jena, Germany;Pharmacy of University Hospital Jena, D-07740, Erlanger Allee 101, Jena, Germany;

关键词: Percutaneous Coronary Intervention;    Abciximab;    Percutaneous Coronary Intervention;    Coronary Flow Velocity Reserve;    ReoPro;   

DOI  :  10.1186/1476-7120-10-21

 received in 2012-02-22, accepted in 2012-05-21,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundEmbolization of atherosclerotic debris from the rupture of a vulnerable atherosclerotic plaque occurs iatrogenically during percutaneous coronary interventions (PCI) and can induce myocardial necrosis. These microembolizations are detected as high intensity transient signals (HITS) using intracoronary Doppler technology.Presentation of the hypothesisIn the presented study we will test if abciximab (ReoPro®) infusion reduces high intensity transient signals in patients with stable angina pectoris undergoing PCI in comparison to standard therapy alone.Testing the hypothesisThe High Intensity Transient Signals ReoPro® (HITS-RP) study will enroll 60 patients. It is a prospective, single center, randomized, double-blinded, controlled trial. The study is designed to compare the efficacy of intravenous abciximab administration for reduction of microembolization during elective PCI. Patients will be randomized in a 1:1 fashion to abciximab or placebo infusion. The primary end point of the HITS-RP-Study is the number of HITS during PCI measured by intracoronary Doppler wire. Secondary endpoints are bleeding complications, elevation of cardiac biomarkers or ECG changes after percutaneous coronary interventions, changes in coronary flow velocity reserve, hs-CRP elevation, any major adverse cardio-vascular event during one month follow-up.Implications of the hypothesisThe HITS-RP-Study addresses important questions regarding the efficacy of intravenous abciximab administration in reducing microembolization and periprocedural complications in stable angina pectoris patients undergoing PCI.Trial registrationThe trial is registered under http://www.drks-neu.uniklinik-freiburg.de/drks_web/:DRKS00000603.

【 授权许可】

CC BY   
© Kretzschmar et al.; licensee BioMed Central Ltd. 2012