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

NCT04599361 | Completed

• 2 other identifiers: 01VSF18010DRKS00022175
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease

Keywords

Chronic coronary heart disease; myocardial revascularization; heart team; decision making; cardiology; heart surgery

Outcome Measures

Primary Outcomes (1)

• Guideline compliance

  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

  2 years

Secondary Outcomes (3)

• Heart teams

  2 years

• Patient participation

  2 years

• Decision making process

  2 years

Study Arms (1)

Patients with CHD

outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany Patients 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) Patients will receive questionnaires.

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany

You may qualify if:

• 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)

Sponsors & Collaborators

• InGef - Institute for Applied Health Research Berlin GmbH: lead
• University of Education Freiburg: collaborator
• Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG): collaborator
• Stiftung Institut fuer Herzinfarktforschung: collaborator
• Universitätsklinikum Köln: collaborator
• BARMER: collaborator
• Techniker Krankenkasse: collaborator

Study Sites (1)

Pädagogische Hochschule Freiburg Public Health & Health Education

Freiburg im Breisgau, Germany

Location

Related Links

• The official website of the REVASK project

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jochen Walker, Dr. med.

  InGef - Institute for Applied Health Research Berlin GmbH; Spittelmarkt 12, 10117 Berlin

  STUDY CHAIR

• Andreas Beckmann, Dr. med.

  Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)

  PRINCIPAL INVESTIGATOR

• Uwe Zeymer, Prof. Dr. med.

  Stiftung Institut für Herzinfarktforschung (IHF)

  PRINCIPAL INVESTIGATOR

• Peter Ihle

  PMV forschungsgruppe, Universitätsklinikum Köln

  PRINCIPAL INVESTIGATOR

• Ursula Marschall, Dr.med.

  BARMER

  PRINCIPAL INVESTIGATOR

• Ines Meier, Dr.

  Techniker Krankenkasse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 22, 2020
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)