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

Autor: Samuel Sossalla, Lars S. Maier, Florian Zeman, Norbert Frey, Michael Koller, Franziska Koll, Astrid Dempfle, Michael Wester
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Angina pectoris
medicine.medical_treatment
610 Medizin
Medicine (miscellaneous)
Chronic coronary syndrome
Coronary Artery Disease
030204 cardiovascular system & hematology
Chest pain
Angina
Coronary artery disease
Study Protocol
03 medical and health sciences
Percutaneous Coronary Intervention
0302 clinical medicine
Quality of life
Internal medicine
Humans
Multicenter Studies as Topic
Chronic coronary syndrome
Stable coronary artery disease
Placebo effect
Angina pectoris
Medicine
Pharmacology (medical)
Prospective Studies
cardiovascular diseases
030212 general & internal medicine
Randomized Controlled Trials as Topic
ddc:610
lcsh:R5-920
Placebo effect
business.industry
Percutaneous coronary intervention
medicine.disease
Coronary arteries
Clinical trial
Treatment Outcome
medicine.anatomical_structure
Conventional PCI
Quality of Life
Stable coronary artery disease
medicine.symptom
lcsh:Medicine (General)
business
Zdroj: Trials, Vol 21, Iss 1, Pp 1-11 (2020)
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04710-7
Popis: Background Stable 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 methods The 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. Discussion The 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 registration German Clinical Trials Register DRKS00017524. Registered on 5 July 2019
Databáze: OpenAIRE
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