Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT06871514

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

Led by dr.Frank L.J. Visseren · Updated on 2025-03-12

1200

Participants Needed

8

Research Sites

201 weeks

Total Duration

On this page

Sponsors

D

dr.Frank L.J. Visseren

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Established ASCVD with at least 30 days since last cardiovascular event or diagnosis
  • Documented ASCVD according to 2021 European Society of Cardiology guidelines, confirmed clinically or by imaging
  • Age between 40 and 80 years
  • Attending Cardiology or Vascular Medicine outpatient clinics
  • Sufficient understanding of the Dutch language
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Participating in other interventional medication studies or studies affecting therapy plan
  • Life expectancy less than 2 years as assessed by a healthcare professional
  • Inability to obtain individual risk predictions with SMART2 model due to:
    • Systolic Blood Pressure less than 90 mmHg or greater than 200 mmHg
    • Total cholesterol less than 2.5 mmol/L or greater than 8 mmol/L
    • HDL cholesterol less than 0.6 mmol/L or greater than 2.5 mmol/L
    • LDL cholesterol less than 0.1 mmol/L or greater than 7.4 mmol/L
    • Estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2 or dialysis
    • Active treatment for malignancy, pregnancy, history of organ transplantation, or liver failure
  • Previous participation in the 2-DECIDE study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands, 1815 JD

Not Yet Recruiting

2

Meander Medisch Centrum

Amersfoort, Netherlands, 3813 TZ

Not Yet Recruiting

3

Deventer Ziekenhuis

Deventer, Netherlands, 7416 SE

Actively Recruiting

4

Ziekenhuis Gelderse Vallei

Ede, Netherlands, 6716 RP

Not Yet Recruiting

5

Radboudumc

Nijmegen, Netherlands, 6525 GA

Not Yet Recruiting

6

HagaZiekenhuis

The Hague, Netherlands, 2545 AA

Not Yet Recruiting

7

Diakonessenhuis

Utrecht, Netherlands, 3582 KE

Actively Recruiting

8

UMC Utrecht

Utrecht, Netherlands, 3584 CX

Not Yet Recruiting

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Research Team

E

Elbrich Wempe, MD, PhD candidate

CONTACT

S

Steven Hageman, Assistant professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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