The online version of this article (doi:10.1186/1476-7120-10-21) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
DK designed the study protocol and drafted the manuscript. SO and AY designed the study protocol. SU and TCP participated in study design. TL performed statistical analysis. MF conceived of the study and helped to draft the manuscript. HRF and CJ conceived of the study. All authors reviewed the manuscript. HRF and MF are the scientific supervisors of the project. DK is the corresponding author. All authors read and approved the final version of the manuscript.
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.
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.
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.
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.
The trial is registered under http://www.drks-neu.uniklinik-freiburg.de/drks_web/:DRKS00000603.
Authors’ original file for figure 112947_2012_422_MOESM1_ESM.pdf
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- 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
Tudor C Pörner
Hans R Figulla
- BioMed Central
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