Improving decision-making support for patients with cardiovascular disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance the way patients with cardiovascular diseases understand their treatment options by implementing a decision support intervention. It focuses on facilitating shared decision-making between patients and healthcare providers, where doctors will spend additional time discussing treatment alternatives. Patients will complete questionnaires after their clinic visits to evaluate the effectiveness of this approach compared to usual care. The study targets individuals with established atherosclerotic cardiovascular disease (ASCVD) to assess the impact of improved communication on patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Deventer Ziekenhuis
  Deventer, Netherlands Recruiting
• Diakonessenhuis
  Utrecht, Netherlands Recruiting
• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands Not yet recruiting
• Meander Medisch Centrum
  Amersfoort, Netherlands Not yet recruiting
• Ziekenhuis Gelderse Vallei
  Ede, Netherlands Not yet recruiting
• Radboudumc
  Nijmegen, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Elbrich Wempe, MD, PhD candidate
• Email: 2-DECIDE@umcutrecht.nl
• Phone: 003188 75 555 55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.