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

NCT ID: NCT04599361

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Education Freiburg

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role collaborator

Universitätsklinikum Köln

OTHER

Sponsor Role collaborator

BARMER

OTHER

Sponsor Role collaborator

Techniker Krankenkasse

OTHER

Sponsor Role collaborator

InGef - Institute for Applied Health Research Berlin GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jochen Walker, Dr. med.

Role: STUDY_CHAIR

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

Andreas Beckmann, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Uwe Zeymer, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Stiftung Institut für Herzinfarktforschung (IHF)

Peter Ihle

Role: PRINCIPAL_INVESTIGATOR

PMV forschungsgruppe, Universitätsklinikum Köln

Ursula Marschall, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

BARMER

Ines Meier, Dr.

Role: PRINCIPAL_INVESTIGATOR

Techniker Krankenkasse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pädagogische Hochschule Freiburg Public Health & Health Education

Freiburg im Breisgau, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Related Links

Access external resources that provide additional context or updates about the study.

https://revask.de/

The official website of the REVASK project

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DRKS00022175

Identifier Type: REGISTRY

Identifier Source: secondary_id

01VSF18010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Framingham Heart Study
NCT00005121 COMPLETED