An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: No treatment given


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM patients seen in routine practice<br>All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions. | Other: No treatment given<br>* No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack | Percentage of participants (Y/N). | Day 1 | 
| Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures | Percentage of participants (Y/N). | Day 1 | 
| 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) | Percentage of participants (Y/N). | Day 1 | 
| Diagnosed with asymptomatic heart failure | Percentage of participants (Y/N). | Day 1 | 
| Hospitalisation for heart failure | Percentage of participants (Y/N). | Day 1 | 
| Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation | Percentage of participants (Y/N). | Day 1 | 
| Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease | Percentage of participants (Y/N). | Day 1 | 
| 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 | Percentage of participants (Y/N). | Day 1 | 
| Diagnosed with carotid artery disease | Percentage of participants (Y/N). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS) | Percentage of participants (Y/N). | Day 1 |