NCT03786406|Completed

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

EU-CAPTURE

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN2211-4423U1111-1207-2816

Study Type

observational

Target

2,275

Locations

3 countries

Sites

Timeline

RegisteredDec 2018

StartedDec 2018

CompletionMay 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,275

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach

3 countries

41 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

December 3, 2018

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed

Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

December 20, 2018

Last Update Submit

June 19, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (9)

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 Outcomes (1)

High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
Day 1

Study Arms (1)

T2DM patients seen in routine practice

All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions.

Other: No treatment given

Interventions

No treatment givenOTHER

No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.

T2DM patients seen in routine practice

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will consist of male and female adults diagnosed with (type 2 diabetes mellitus (T2DM).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.