Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT03428061
Eligibility Criteria:
Inclusion criteria for patients with CVD:
* Patients with a history of atherosclerotic CVD defined as documented angina pectoris, myocardial infarction, chronic ischemic heart disease, coronary sclerosis, transient ischaemic attack (TIA), cerebral infarction, intermittent claudication or aneurysm of the abdominal aorta
* The CV risk of the patient is managed in primary care, not in the hospital or outpatient clinic by a medical specialist
* Age between 40 and 80 years
Inclusion criteria for high risk patients:
* Use of blood pressure lowering or lipid lowering drugs
* A 10 -years CV risk \> 10%, based on the Dutch guideline for CVRM and i) either 1 strongly cardiovascular risk enhancing factor or 2 mildly cardiovascular risk enhancing factors (see table 6) or ii) \> 1 CV risk factor (current smoking, SBP\>140 mmHg, LDL\>2.5 mmol/L, TC/HDL-ratio \> 8, chronic renal impairment (age \< 65 years: eGFR \< 60 ml/min/1,73 m2; age ≥ 65 years: eGFR \< 45 ml/min/1,73 m2, and/or (micro)albuminuria).
* A 10-year CV risk of \>20% and \> 1 CV risk factor (current smoking, SBP\>140 mmHg, LDL\>2.5 mmol/L, TC/HDL-ratio \> 8, chronic renal impairment (age \< 65 years: eGFR \< 60 ml/min/1,73 m2; age ≥ 65 years: eGFR \< 45 ml/min/1,73 m2, and/or (micro)albuminuria).
* The CV risk of the patient is managed in primary care, not in the hospital or outpatient clinic by a medical specialist
* Age between 40 and 80 years
Exclusion criteria for all patients:
* Diabetes mellitus, as these patients are already included in a disease management program for diabetes mellitus
* Limited life expectancy, as assessed by the GP
* Cognitive impairment, as assessed by the GP
* No Dutch language proficiency
* Staying abroad for longer than three months during the duration of the study.
* The CV risk of the patient is managed in the hospital or outpatient clinic by a medical specialist
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03428061
Study Brief:
Protocol Section:
NCT03428061