Clinical trial NCT03786406: An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes
Official title: A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-12-26
Enrollment: 2275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of male and female adults diagnosed with (type 2 diabetes mellitus (T2DM).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack
timeFrame: Day 1
measure: Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: Diagnosed with asymptomatic heart failure
timeFrame: Day 1
measure: Hospitalisation for heart failure
timeFrame: Day 1
measure: Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation
timeFrame: Day 1
measure: Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Diagnosed with carotid artery disease
timeFrame: Day 1
Secondary outcomes:
measure: High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Benatky nad Jizerou
country: Czechia
facility: Novo Nordisk Investigational Site
city: Boskovice
country: Czechia
facility: Novo Nordisk Investigational Site
city: Brandys nad Labem
country: Czechia
facility: Novo Nordisk Investigational Site
city: Breclav
country: Czechia
facility: Novo Nordisk Investigational Site
city: Chomutov
country: Czechia
facility: Novo Nordisk Investigational Site
city: Hradec Kralove
country: Czechia
facility: Novo Nordisk Investigational Site
city: Kromeriz
country: Czechia
facility: Novo Nordisk Investigational Site
city: Olomouc
country: Czechia
facility: Novo Nordisk Investigational Site
city: Orlova
country: Czechia
facility: Novo Nordisk Investigational Site
city: Ostrava
country: Czechia
facility: Novo Nordisk Investigational Site
city: Ostrava
country: Czechia
facility: Novo Nordisk Investigational Site
city: Plzen
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha
country: Czechia
facility: Novo Nordisk Investigational Site
city: Chartres
country: France
facility: Novo Nordisk Investigational Site
city: Courpière
country: France
facility: Novo Nordisk Investigational Site
city: Le Creusot
country: France
facility: Novo Nordisk Investigational Site
city: Lyon
country: France
facility: Novo Nordisk Investigational Site
city: Montélimar
country: France
facility: Novo Nordisk Investigational Site
city: Saint Saens
country: France
facility: Novo Nordisk Investigational Site
city: Sathonay-Camp
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: Tarare
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Albano Laziale
country: Italy
facility: Novo Nordisk Investigational Site
city: Ariano Irpino
country: Italy
facility: Novo Nordisk Investigational Site
city: Bagno a Ripoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Brindisi
country: Italy
facility: Novo Nordisk Investigational Site
city: Catanzaro
country: Italy
facility: Novo Nordisk Investigational Site
city: Fano
country: Italy
facility: Novo Nordisk Investigational Site
city: Ferrara
country: Italy
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Messina
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Negrar (VR)
country: Italy
facility: Novo Nordisk Investigational Site
city: Orvieto
country: Italy
facility: Novo Nordisk Investigational Site
city: Partinico (PA)
country: Italy
facility: Novo Nordisk Investigational Site
city: Ravenna
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Rozzano (MI)
country: Italy
facility: Novo Nordisk Investigational Site
city: Savigliano (CN)
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.
citation: Vencio S, Vianna AGD, da Silva MACF, Precoma DB. Contemporary (2019) prevalence of cardiovascular disease in adults with type 2 diabetes in Brazil: the cross-sectional CAPTURE study. Diabetol Metab Syndr. 2022 Jan 10;14(1):5. doi: 10.1186/s13098-021-00775-9.