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

Sponsor

InGef - Institute for Applied Health Research Berlin GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04599361

Collaborator

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

1,000

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Guideline compliance [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 Outcome Measures

Heart teams [2 years]
Frequency and quality of heart teams
Patient participation [2 years]
extent of patient participation in the decision making process
Decision making process [2 years]
importance of clinical parameters in the decision-making process (e.g. syntax scores, iFR, FFR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pädagogische Hochschule Freiburg Public Health & Health Education	Freiburg		Germany

Sponsors and Collaborators

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

Investigators

Study Chair: Jochen Walker, Dr. med., InGef - Institute for Applied Health Research Berlin GmbH; Spittelmarkt 12, 10117 Berlin
Principal Investigator: 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