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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Wester, Michael Koll, Franziska Zeman, Florian Dempfle, Astrid Koller, Michael Frey, Norbert Maier, Lars S. Sossalla, Samuel |
| Abstract | 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 |
| Related Links | https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-020-04710-7.pdf |
| Ending Page | 11 |
| Page Count | 11 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17456215 |
| DOI | 10.1186/s13063-020-04710-7 |
| Journal | Trials |
| Issue Number | 1 |
| Volume Number | 21 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2020-10-08 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Chronic coronary syndrome Stable coronary artery disease Placebo effect Angina pectoris Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Pharmacology (medical) |
| Journal Impact Factor | 2/2023 |
| 5-Year Journal Impact Factor | 2.1/2023 |
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