A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 2,275
- Locations
- 1
- Primary Endpoint
- Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation
Study Overview
Brief Summary
The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
- •Male or female, age greater than or equal to 18 years at the time of signing informed consent
- •Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of signing the informed consent
Exclusion Criteria
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Diagnosed with Type 1 diabetes
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Patients with known congenital heart disease/malformation
Outcomes
Primary Outcomes
Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation
Time Frame: Day 1
Percentage of participants (Y/N).
Diagnosed with symptomatic heart failure: New York Heart Association Functional Classification (NYHA) (group IIIV) and/or left ventricular ejection fraction (LVEF) greater than or equal to 50 percent, LVEF 40-49 percent and LVEF less than 40 percent)
Time Frame: Day 1
Percentage of participants (Y/N).
Diagnosed with asymptomatic heart failure
Time Frame: Day 1
Percentage of participants (Y/N).
Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease
Time Frame: Day 1
Percentage of participants (Y/N).
Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures
Time Frame: Day 1
Percentage of participants (Y/N).
Diagnosed with carotid artery disease
Time Frame: Day 1
Percentage of participants (Y/N).
Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation
Time Frame: Day 1
Percentage of participants (Y/N).
Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack
Time Frame: Day 1
Percentage of participants (Y/N).
Hospitalisation for heart failure
Time Frame: Day 1
Percentage of participants (Y/N).
Secondary Outcomes
- High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)(Day 1)