Skip to main content
OpenTrials
Completed

NCT Number: NCT04599361

Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)

Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes of death in Germany. Treatment options include widening of the narrowed / blocked coronary vessel via catheter and stent or bypass surgery in which the narrowed vessel sites are bridged. The "German National Disease Management Guideline on cCHD" helps doctors to decide which treatment is most appropriate for the severity of vascular damage and possible concomitant diseases of the patient. Nevertheless, there are other factors determining treatment decision. For example, the equipment or preferences of the hospital or department in which patients are admitted, play a role in the decision.

The aim of the REVASK project is to investigate whether and to what extent the collaboration of cardiology and heart surgery specialists in so-called "heart teams" influences the decision on therapy.

For this purpose, doctors and patients will be interviewed about how the treatment decision was made and how satisfied both sides are with the outcome of the treatment and the decision. In addition, claims data from several German health insurance companies (Techniker, BARMER, Betriebs- und Innungskrankenkassen) will be analyzed. Treatment data, which is documented as usual by the treating medical staff and passed on to the health insurance companies for accounting purposes, is used. Furthermore, treatment data recorded in the registers of the professional societies is analyzed.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pädagogische Hochschule Freiburg Public Health & Health Education

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • with chronic coronary heart disease
  • and 2- or 3-vessel or main-vessel disease
  • who are being treated at one of the recruitment sites
  • with a promptly planned intervention for myocardial revascularization
  • who are insured with pre-specified German health insurance companies (BARMER or TK)

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Guideline compliance

    Time frame: 2 years

    Guidelines-compliant therapy in patients with chronic CHD (2- or 3-vessel or main vessel disease) according to German National Disease Management Guideline on chronic coronary heart disease

Secondary outcomes

  1. Heart teams

    Time frame: 2 years

    Frequency and quality of heart teams

  2. Patient participation

    Time frame: 2 years

    extent of patient participation in the decision making process

  3. Decision making process

    Time frame: 2 years

    importance of clinical parameters in the decision-making process (e.g. syntax scores, iFR, FFR)

Sponsors and collaborators

Lead sponsor

InGef - Institute for Applied Health Research Berlin GmbH

Industry

Collaborators

  • BARMER
  • Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)
  • Stiftung Institut fuer Herzinfarktforschung
  • Techniker Krankenkasse
  • University of Education Freiburg
  • Universitätsklinikum Köln

Registry information

Acronym: REVASK

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.