Effects of visualization of successful revascularization on chest pain and quality of life in chronic coronary syndrome: study protocol for the multi-center, randomized, controlled PLA-pCi-EBO-pilot-trial

Trials

Michael Koller¹  Florian Zeman¹  Norbert Frey²  Astrid Dempfle³  Michael Wester⁴  Samuel Sossalla⁴  Franziska Koll⁴  Lars S. Maier⁴ 

[1] Centre for Clinical Studies, University Medical Centre, Regensburg, Germany;Department of Internal Medicine III, University of Kiel, Kiel, Germany;Institute of Medical Informatics and Statistics, University Medical Centre Schleswig-Holstein, Campus Kiel, Kiel, Germany;University Heart Centre Regensburg, Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany;

关键词: Chronic coronary syndrome;    Stable coronary artery disease;    Placebo effect;    Angina pectoris;   

DOI  :  10.1186/s13063-020-04710-7

来源: Springer

【 摘 要 】

BackgroundStable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is that visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) by itself reduces the symptom burden of stable CAD/CCS.Design and methodsThe PLA-pCi-EBO-pilot-trial is a prospective, multi-center, randomized, controlled investigator-initiated pilot trial to study the effect of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CAD/CCS. All patients with stable CAD/CCS and successful PCI will be screened. One hundred forty four patients with a frequency of AP ≥ 2/week will be randomized 1:1 stratified for AP frequency > 1/day. The control group will receive the common written procedural report on the procedure. Patients in the intervention group will additionally be given a printout picture of their coronary angiogram both before and after PCI. Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6 months after PCI.DiscussionThe PLA-pCi-EBO-pilot-trial evaluates the effect of visual angiographic result demonstration on disease symptoms and QoL in patients with stable CAD/CCS on top of PCI. A positive outcome of our study would encourage the routine use of angiographic picture demonstration and has thus the potential to change daily routine in the catheterization laboratory.Trial registrationGerman Clinical Trials Register DRKS00017524. Registered on 5 July 2019

【 授权许可】

CC BY