Trial document




drksid header

  DRKS00017524

Trial Description

start of 1:1-Block title

Title

Effects of visualization of successful revascularization on chest pain and quality of life

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

The PLA-pCi-EBO-Trial

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Coronary artery disease is a very common disease in the age group of 40-79 years in Germany. Despite an elevated risk of myocardial infarction and heart failure, chest pain and shortness of breathare symptoms that often lead to reduced quality of life. Treatment of these symptoms is often insufficient. In studies of drugs that help to reduce chest pain and shortness of breath, there was often a large placebo effect. This means that not only the patients that received the actual drug but also the patients that received a pill without the drug reported an amelioration of the discomfort. There are many possible explanations of this so called placebo effect. One involves that patients that take part in a trial are more carefully examined and receive more detailled explanations about their disease. This study is designed to further examine this explanation. Therefore, 134 patients will be randomized by chance into two groups. Patients that have chest pain and a newly implanted stent can participate in this study. All patients will be treated according to the current guidelines and recommendations. One half of the patients will only receive an oral explanation of the procedure and the results and the written report as it is currently the usual clinical practice. The other half wil receive a print out of the pictures of the procedure before and after stent implantation. The symptoms of chest pain and quality of life will be evaluated during the hospital stay as well as one and six months after using a questionnaire.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Coronary heart disease is a highly prevalent condition and despite optimal treatment, symptoms including dyspnea and pain from angina pectoris are often only poorly controlled. Past studies showed large placebo effects of medical or interventional treatment.
The objective of this study is to examine the effect of the visual demonstration of the successful coronary intervention on quality of life and pain due to angina pectoris symptoms in patients with relevant coronary stenosis receiving interventional treatment.
After randomization, the intervention group receives a picture of the coronary stenosis before and after successful coronary intervention. The control group will receive a written report.
The Seattle Angina Questionnaire and the NYHA score which will be measured at hospital admission, 1 and 6 months after the coronary intervention in order to determine a potential effect on chest pain with a possible resulting improvement on quality of life.
This study is designed as a pilot study to allow for a precise estimation for further confirmatory studies.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017524
  •   2019/07/05
  •   [---]*
  •   yes
  •   Approved
  •   19-1261-101, Ethikkommission an der Universität Regensburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I25 -  Chronic ischaemic heart disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The patients in the intervention group receive a print out of the pictures of the procedure before and after stent implantation.
  •   Control group: According to current clinical praxis, the patient receives a brief explanation and a written report of the angioplasty.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The Seattle Angina Questionnaire (SAQ) derived Quality of life score is assessed during the hospital stay of the angioplasty. This is repeated after 1 and 6 months in a phone interview. Primary endpoint of this study is the change in the quality of life as it is meassured in the Seattle Angina Questionnaire one and six months after stent implantation. This questionnaire is filled out by the study doctor together with the patient during the initiatl hospital stay. The follow up after 1 and 6 months is performed in a telephone interview.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary endpoints are changes in the other derived SAQ-Scores (physical limitation, angina stability, Angina frequency, treatment satisfaction, disease perception) and the dyspnea (NYHA Score) after 1 and 6 months compared to the intial assessment during the initial hospital stay.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/07/07
  •   134
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- symptomatic CAD (coronary artery disease)
- CCS >=2 (Canadian Cardiovascular Society)
- AP-frequency >=2/week
- German-speaking

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- EF <35% (ejection fraction)
- severe pulmonary disease
- impaired vision
- impaired hearing
- dementia
- drugs with influence on the opiod system
- high grade valve impairment
- Hb <=7 mg/dL
- participation in other interventional clinical trial

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Regensburg
    • Mr.  Professor  Samuel  Sossalla 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Regensburg
    • Mr.  Professor  Samuel  Sossalla 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universistätsklinikum Regensburg
    • Mr.  Professor  Samuel  Sossalla 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Regensburg
    • Mr.  Professor  Samuel  Sossalla 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.