Phase
Condition
Atherosclerosis
Vascular Diseases
Treatment
No Intervention: usual care
2-DECIDE intervention: decision support for cardiovascular risk management
Clinical Study ID
Ages 40-80 All Genders
Study Summary
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
Connect with a study center
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD
NetherlandsSite Not Available
Meander Medisch Centrum
Amersfoort, 3813 TZ
NetherlandsSite Not Available
HagaZiekenhuis
Den Haag, 2545 AA
NetherlandsSite Not Available
Deventer Ziekenhuis
Deventer, 7416 SE
NetherlandsActive - Recruiting
Ziekenhuis Gelderse Vallei
Ede, 6716 RP
NetherlandsSite Not Available
Radboudumc
Nijmegen, 6525 GA
NetherlandsSite Not Available
Diakonessenhuis
Utrecht, 3582 KE
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
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