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

Last updated: March 11, 2025
Sponsor: dr.Frank L.J. Visseren
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Vascular Diseases

Treatment

No Intervention: usual care

2-DECIDE intervention: decision support for cardiovascular risk management

Clinical Study ID

NCT06871514
24U-1636
  • Ages 40-80
  • All Genders

Study Summary

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

Inclusion

Inclusion criteria:

  • Established ASCVD

  • At least 30 days since last CVD event and/or the diagnosis of ASCVD. If no CVDevents have occurred, imaging confirming ASCVD must have been conducted atleast 30 days prior.

  • Documented ASCVD (defined according to the 2021 European Society of Cardiologyguideline), which includes ASCVD established clinically or demonstratedunequivocally by imaging:

  • Clinically documented ASCVD includes previous myocardial infarction, acute coronarysyndrome, coronary revascularization (Percutaneous Coronary Intervention (PCI) orCoronary Artery Bypass Surgery (CABG)), and other arterial revascularizationprocedures, ischemic stroke or transient ischemic attack, and peripheral arterydisease (from Fontaine stage II). Angina pectoris (stable) without imaging evidenceof atherosclerosis does not qualify as ASCVD.

  • ASCVD unambiguously identified through imaging, includes significant stenosis (>50%)on coronary angiography, computed tomography angiography, or carotic ultrasound. Italso includes aortic aneurysms measuring ≥3cm. Only Carotid Intima-Media Thicknessmeasurements (cIMT), Coronary Artery Calcium scoring or abnormal ankle-brachialindex 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 beingadministered in Dutch).

  • Written informed consent must be provided. Although the proposed intervention is notsubject to the WMO, informed consent is required for the collection and processingof data, including the distribution of questionnaires.

Exclusion

Exclusion criteria:

  • Patients currently participating in other interventional medication studies, orstudies that directly affect the therapy plan

  • Remaining life expectancy of less than 2 years as assessed by a consultinghealthcare professional (these patients have no indication for cardiovascular riskmanagement)

  • Patients for whom individual risk predictions with the SMART2 model are notfeasible:

  • 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, orliver failure

  • Previous participation in 2-DECIDE

Study Design

Total Participants: 1200
Treatment Group(s): 2
Primary Treatment: No Intervention: usual care
Phase:
Study Start date:
February 18, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ
    Netherlands

    Site Not Available

  • HagaZiekenhuis

    Den Haag, 2545 AA
    Netherlands

    Site Not Available

  • Deventer Ziekenhuis

    Deventer, 7416 SE
    Netherlands

    Active - Recruiting

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP
    Netherlands

    Site Not Available

  • Radboudumc

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Diakonessenhuis

    Utrecht, 3582 KE
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

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