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

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT04599361
• Lead Sponsor: InGef - Institute for Applied Health Research Berlin GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-22
• Study Start: 2021-04-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Pädagogische Hochschule Freiburg Public Health & Health Education; 🇩🇪 Freiburg, Germany