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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. und 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, S. 838.

Veröffentlichungsdatum dieses Volltextes: 23 Feb 2021 10:49
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.45051


Zusammenfassung

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

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftTrials
Verlag:BMC
Ort der Veröffentlichung:LONDON
Band:21
Seitenbereich:S. 838
Datum8 Oktober 2020
InstitutionenMedizin > Lehrstuhl für Innere Medizin II
Medizin > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identifikationsnummer
WertTyp
10.1186/s13063-020-04710-7DOI
Stichwörter / KeywordsPLACEBO; ANGINA; RANOLAZINE; IVABRADINE; IMPACT; Chronic coronary syndrome; Stable coronary artery disease; Placebo effect; Angina pectoris
Dewey-Dezimal-Klassifikation600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenJa
URN der UB Regensburgurn:nbn:de:bvb:355-epub-450519
Dokumenten-ID45051

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