title: 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.
abstract: BACKGROUND
  Embolization 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.
  
  
  OBJECTIVE
  In 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.
  
  
  METHODS
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  The trial is registered under http://www.drks-neu.uniklinik-freiburg.de/drks_web/:DRKS00000603.
authors.affiliation: Department of Internal Medicine I, Division of Cardiology, University Hospital Jena, Erlanger Allee 101, D-07740, Jena, Germany. daniel.kretzschmar@med.uni-jena.de
authors.forename: Daniel
authors.initials: D
authors.lastname: Kretzschmar
authors.forename: Christian
authors.initials: C
authors.lastname: Jung
authors.forename: Sylvia
authors.initials: S
authors.lastname: Otto
authors.forename: Stephan
authors.initials: S
authors.lastname: Utschig
authors.forename: Michael
authors.initials: M
authors.lastname: Hartmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Lehmann
authors.forename: Atilla
authors.initials: A
authors.lastname: Yilmaz
authors.forename: Tudor C
authors.initials: TC
authors.lastname: Pörner
authors.forename: Hans R
authors.initials: HR
authors.lastname: Figulla
authors.forename: Markus
authors.initials: M
authors.lastname: Ferrari
mesh_terms: D000077284:Abciximab; D000293:Adolescent; D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000150:complications* / Q000601:surgery*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000925:Anticoagulants / Q000627:therapeutic use; D004311:Double-Blind Method; D015150:Echocardiography, Doppler / Q000379:methods*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D013927:Thrombosis / Q000209:etiology* / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab