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

Recruiting now · Not applicable

Conditions studied: Atherosclerotic Cardiovascular Diseases, Shared-decision Making

In brief

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.

Key facts

Study ID

NCT06871514

Run by

dr.Frank L.J. Visseren

People needed

1200

Starts

2025-02-18

Expected to finish

2028-12-31

Last updated by the study team

2025-03-12

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Diakonessenhuis — Utrecht, Netherlands (enrolling)
• Deventer Ziekenhuis — Deventer, Netherlands (enrolling)
• Ziekenhuis Gelderse Vallei — Ede, Netherlands
• Radboudumc — Nijmegen, Netherlands
• HagaZiekenhuis — The Hague, Netherlands
• Noordwest Ziekenhuisgroep — Alkmaar, Netherlands
• UMC Utrecht — Utrecht, Netherlands
• Meander Medisch Centrum — Amersfoort, Netherlands

Full record on ClinicalTrials.gov

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