Coronary Heart DiseaseREVASKNCT04599361
Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)
An observational study of Coronary Heart Disease, run by InGef - Institute for Applied Health Research Berlin GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 385 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Pädagogische Hochschule Freiburg Public Health & Health Education
Freiburg im Breisgau
About this study
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
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
Heart teams
Frequency and quality of heart teams
Measured: 2 years
Patient participation
extent of patient participation in the decision making process
Measured: 2 years
Decision making process
importance of clinical parameters in the decision-making process (e.g. syntax scores, iFR, FFR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- InGef - Institute for Applied Health Research Berlin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Education Freiburg, Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG), Stiftung Institut fuer Herzinfarktforschung, Universitätsklinikum Köln, BARMER, Techniker Krankenkasse
- Responsible party
- Sponsor
- Investigators
- Jochen Walker, Dr. med., Study chair, InGef - Institute for Applied Health Research Berlin GmbH; Spittelmarkt 12, 10117 BerlinAndreas Beckmann, Dr. med., Principal investigator, Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)Uwe Zeymer, Prof. Dr. med., Principal investigator, Stiftung Institut für Herzinfarktforschung (IHF)Peter Ihle, Principal investigator, PMV forschungsgruppe, Universitätsklinikum KölnUrsula Marschall, Dr.med., Principal investigator, BARMERInes Meier, Dr., Principal investigator, Techniker Krankenkasse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599361
- Sponsor's protocol ID
- 01VSF18010
- Other IDs
- DRKS00022175
- Acronym
- REVASK
- Status last verified
- Feb 2023
- First submitted
- 11 Sep 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data can be shared with persons or institutions with a legitimate scientific interest after consultation in the consortium and only in pseudonymised form and within the scope of the EU-GDPR
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)
- ClinicalTrials.gov ID
- NCT04599361
- Acronym / sponsor ID
- REVASK / 01VSF18010
- Conditions
- Coronary Heart Disease
- Keywords
- Chronic coronary heart disease, myocardial revascularization, heart team, decision making, cardiology, heart surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- InGef - Institute for Applied Health Research Berlin GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University of Education Freiburg, Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG), Stiftung Institut fuer Herzinfarktforschung, Universitätsklinikum Köln, BARMER, Techniker Krankenkasse
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Guideline compliance
Time frame: 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
3 secondary outcomes
Heart teams
Time frame: 2 years
Patient participation
Time frame: 2 years
Decision making process
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- The official website of the REVASK projectLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Research data can be shared with persons or institutions with a legitimate scientific interest after consultation in the consortium and only in pseudonymised form and within the scope of the EU-GDPR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Walker, Dr. med. study chair
InGef - Institute for Applied Health Research Berlin GmbH; Spittelmarkt 12, 10117 Berlin
Andreas Beckmann, Dr. med. principal investigator
Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)
Uwe Zeymer, Prof. Dr. med. principal investigator
Stiftung Institut für Herzinfarktforschung (IHF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by InGef - Institute for Applied Health Research Berlin GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline compliance (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.