Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease

Launched by DR.FRANK L.J. VISSEREN · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at ways to help patients with heart and blood vessel diseases, known as atherosclerotic cardiovascular diseases (ASCVD), make better decisions about their treatment options. The goal is to improve the conversations between doctors and patients, ensuring that patients understand their choices and can participate in decisions about their care. As part of the study, some patients will have more detailed discussions with their doctors, and afterward, they will fill out questionnaires to share their experiences.

To be eligible for this trial, participants should be between 40 and 80 years old and must have a confirmed diagnosis of ASCVD, such as a previous heart attack or stroke. They need to be able to understand Dutch since the questionnaires are in that language. Patients currently involved in other medication studies or with certain health issues might not qualify. If you join the study, you can expect to engage in in-depth discussions about your treatment options and provide feedback on the process to help improve patient care in the future.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 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.
• * Documented ASCVD (defined according to the 2021 European Society of Cardiology guideline), which includes ASCVD established clinically or demonstrated unequivocally by imaging:
• • 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.
• • Age 40-80 years (to allow for individual risk predictions with the SMART2 model
• • Patient attending the Cardiology or Vascular Medicine outpatient clinic
• • Sufficient understanding of the Dutch language (due to the questionnaires being administered in Dutch).
• • Written informed consent must be provided. Although the proposed intervention is not subject to the WMO, informed consent is required for the collection and processing of data, including the distribution of questionnaires.
• Exclusion criteria:
• • 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)
• * Patients for whom individual risk predictions with the SMART2 model are not feasible:
• • Systolic Blood Pressure (SBP) \<90 mmHg or \>200 mmHg
• • Total cholesterol \<2.5mmol/L or \>8 mmol/L
• • High-Density Lipoprotein (HDL) cholesterol \<0.6mmol/L or \>2.5 mmol/L
• • Low-Density Lipoprotein (LDL) \<0.1 mmol/L or \>7.4 mmol /L
• • Estimated Glomerular Filtration Rate (eGFR) \<30ml/min/1.73m2 or dialysis
• • Active treatment for malignity, pregnancy, history of organ transplantation, or liver failure
• • Previous participation in 2-DECIDE