Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
Sponsordr.Frank L.J. Visseren
About this trial
This study aims to improve the way patients with cardiovascular diseases are informed about their treatment options. It explores methods to support shared decision-making between patients and doctors. In some cases, doctors will take extra time to discuss treatment options in detail. To assess the impact, some patients will be asked to complete questionnaires after their clinic visits.
Eligibility criteria
Qualifiers
Established ASCVD
At least 30 days since last CVD event and/or the diagnosis of ASCVD. If no CVD events have occurred, imaging confirming ASCVD must have been conducted at least 30 days prior.
Clinically documented ASCVD includes previous myocardial infarction, acute coronary syndrome, coronary revascularization (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery (CABG)), and other arterial revascularization procedures, ischemic stroke or transient ischemic attack, and peripheral artery disease (from Fontaine stage II). Angina pectoris (stable) without imaging evidence of atherosclerosis does not qualify as ASCVD.
ASCVD unambiguously identified through imaging, includes significant stenosis (>50%) on coronary angiography, computed tomography angiography, or carotic ultrasound. It also includes aortic aneurysms measuring ≥3cm. Only Carotid Intima-Media Thickness measurements (cIMT), Coronary Artery Calcium scoring or abnormal ankle-brachial index scores without evidence of stenosis, do not qualify as ASCVD.
Disqualifiers
Patients currently participating in other interventional medication studies, or studies that directly affect the therapy plan
Remaining life expectancy of less than 2 years as assessed by a consulting healthcare professional (these patients have no indication for cardiovascular risk management)
Systolic Blood Pressure (SBP) <90 mmHg or >200 mmHg
Total cholesterol <2.5mmol/L or >8 mmol/L
Trial design
Treatments tested in this trial
- 2-DECIDE intervention: decision support for cardiovascular risk management
- No Intervention: usual care
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
dr.Frank L.J. Visseren
Lead sponsor
UMC Utrecht
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov