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An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes (EU-CAPTURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03786406
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: No treatment given

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Study Type : Observational
Actual Enrollment : 2275 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack [ Time Frame: Day 1 ]
    Percentage of participants (Y/N).

  2. 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).

  3. 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).

  4. Diagnosed with asymptomatic heart failure [ Time Frame: Day 1 ]
    Percentage of participants (Y/N).

  5. Hospitalisation for heart failure [ Time Frame: Day 1 ]
    Percentage of participants (Y/N).

  6. Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation [ Time Frame: Day 1 ]
    Percentage of participants (Y/N).

  7. Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease [ Time Frame: Day 1 ]
    Percentage of participants (Y/N).

  8. 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).

  9. Diagnosed with carotid artery disease [ Time Frame: Day 1 ]
    Percentage of participants (Y/N).


Secondary Outcome Measures :
  1. High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS) [ Time Frame: Day 1 ]
    Percentage of participants (Y/N).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of male and female adults diagnosed with (type 2 diabetes mellitus (T2DM).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786406


Locations
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Czechia
Novo Nordisk Investigational Site
Benatky nad Jizerou, Czechia, 29471
Novo Nordisk Investigational Site
Boskovice, Czechia, 68001
Novo Nordisk Investigational Site
Brandys nad Labem, Czechia, 25001
Novo Nordisk Investigational Site
Breclav, Czechia, 69002
Novo Nordisk Investigational Site
Chomutov, Czechia, 43004
Novo Nordisk Investigational Site
Hradec Kralove, Czechia, 50341
Novo Nordisk Investigational Site
Kromeriz, Czechia, 76701
Novo Nordisk Investigational Site
Olomouc, Czechia, 77900
Novo Nordisk Investigational Site
Orlova, Czechia, 73514
Novo Nordisk Investigational Site
Ostrava, Czechia, 70200
Novo Nordisk Investigational Site
Ostrava, Czechia, 71800
Novo Nordisk Investigational Site
Plzen, Czechia, 30166
Novo Nordisk Investigational Site
Praha, Czechia, 14000
France
Novo Nordisk Investigational Site
Chartres, France, 28000
Novo Nordisk Investigational Site
Courpière, France, 63120
Novo Nordisk Investigational Site
Le Creusot, France, 71200
Novo Nordisk Investigational Site
Lyon, France, 69007
Novo Nordisk Investigational Site
Montélimar, France, 26200
Novo Nordisk Investigational Site
Saint Saens, France, 76680
Novo Nordisk Investigational Site
Sathonay-Camp, France, 69580
Novo Nordisk Investigational Site
Strasbourg, France, 67000
Novo Nordisk Investigational Site
Tarare, France, 69170
Novo Nordisk Investigational Site
Venissieux, France, 69200
Italy
Novo Nordisk Investigational Site
Albano Laziale, Italy, 00041
Novo Nordisk Investigational Site
Ariano Irpino, Italy, 83031
Novo Nordisk Investigational Site
Bagno a Ripoli, Italy, 50012
Novo Nordisk Investigational Site
Brindisi, Italy, 72100
Novo Nordisk Investigational Site
Catanzaro, Italy, 88100
Novo Nordisk Investigational Site
Fano, Italy, 61032
Novo Nordisk Investigational Site
Ferrara, Italy, 44123
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Messina, Italy, 98128
Novo Nordisk Investigational Site
Milano, Italy, 20162
Novo Nordisk Investigational Site
Napoli, Italy, 80100
Novo Nordisk Investigational Site
Negrar (VR), Italy, 37024
Novo Nordisk Investigational Site
Orvieto, Italy, 05018
Novo Nordisk Investigational Site
Partinico (PA), Italy, 90047
Novo Nordisk Investigational Site
Ravenna, Italy, 48121
Novo Nordisk Investigational Site
Roma, Italy, 00161
Novo Nordisk Investigational Site
Rozzano (MI), Italy, 20089
Novo Nordisk Investigational Site
Savigliano (CN), Italy, 12038
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03786406     History of Changes
Other Study ID Numbers: NN2211-4423
U1111-1207-2816 ( Other Identifier: World Health Organization (WHO) )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: https://www.novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases