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

Coronary Heart Disease Clinical Trial

— REVASK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599361
• Other study ID #: 01VSF18010
• Secondary ID: DRKS00022175
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: InGef - Institute for Applied Health Research Berlin GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	Pädagogische Hochschule Freiburg Public Health & Health Education	Freiburg

Sponsors (7)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart teams	Frequency and quality of heart teams	2 years
Secondary	Patient participation	extent of patient participation in the decision making process	2 years
Secondary	Decision making process	importance of clinical parameters in the decision-making process (e.g. syntax scores, iFR, FFR)	2 years

External Links

•   The official website of the REVASK project