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Wester, Michael ; Koll, Franziska ; Zeman, Florian ; Dempfle, Astrid ; Koller, Michael ; Frey, Norbert ; Maier, Lars S. ; Sossalla, Samuel

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

Wester, Michael , Koll, Franziska, Zeman, Florian, Dempfle, Astrid, Koller, Michael, Frey, Norbert , Maier, Lars S. and Sossalla, Samuel (2020) 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 21, p. 838.

Date of publication of this fulltext: 23 Feb 2021 10:49
Article
DOI to cite this document: 10.5283/epub.45051


Abstract

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 ...

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 6months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6months 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



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Details

Item typeArticle
Journal or Publication TitleTrials
Publisher:BMC
Place of Publication:LONDON
Volume:21
Page Range:p. 838
Date8 October 2020
InstitutionsMedicine > Lehrstuhl für Innere Medizin II
Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number
ValueType
10.1186/s13063-020-04710-7DOI
KeywordsPLACEBO; ANGINA; RANOLAZINE; IVABRADINE; IMPACT; Chronic coronary syndrome; Stable coronary artery disease; Placebo effect; Angina pectoris
Dewey Decimal Classification600 Technology > 610 Medical sciences Medicine
StatusPublished
RefereedYes, this version has been refereed
Created at the University of RegensburgYes
URN of the UB Regensburgurn:nbn:de:bvb:355-epub-450519
Item ID45051

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