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

URN to cite this document:

urn:nbn:de:bvb:355-epub-450519 Copy

DOI to cite this document:

10.5283/epub.45051 Copy

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

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Date of publication of this fulltext: 23 Feb 2021 10:49

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Details

Item type:	Article
Open Access Type:	DEAL (Springer Gold)
Journal or Publication Title:	Trials
Publisher:	BMC
Place of Publication:	LONDON
Volume:	21
Page Range:	p. 838
Date:	8 October 2020
Institutions:	Medicine > Lehrstuhl für Innere Medizin II Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number:	Value Type 10.1186/s13063-020-04710-7 DOI
Keywords:	PLACEBO; ANGINA; RANOLAZINE; IVABRADINE; IMPACT; Chronic coronary syndrome; Stable coronary artery disease; Placebo effect; Angina pectoris
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	45051

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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 ...

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 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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Metadata last modified: 29 Sep 2021 07:42

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