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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03811288




Registration number
NCT03811288
Ethics application status
Date submitted
18/01/2019
Date registered
21/01/2019
Date last updated
5/08/2019

Titles & IDs
Public title
An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes
Scientific title
A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation
Secondary ID [1] 0 0
U1111-1215-4005
Secondary ID [2] 0 0
NN2211-4446
Universal Trial Number (UTN)
Trial acronym
CAPTURE-IO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No treatment given

Participants with type 2 diabetes mellitus (T2DM) - T2DM patients being managed in both primary and specialist care in 10 selected countries.


Other interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants with a history of established cardiovascular disease (CVD) - Participants having a history of established CVD, i.e. who have been diagnosed with any one of the following listed conditions (yes/no): Cerebrovascular disease, cardiovascular disease, symptomatic heart failure, asymptomatic heart failure, hospitalisation for heart failure, cardiac arrhythmia, aortic disease, peripheral artery disease or carotid artery disease.
Timepoint [1] 0 0
Day 1
Secondary outcome [1] 0 0
Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS) - Percentage of participants (yes/no). High risk: more than 20 percent over 10 years.
Timepoint [1] 0 0
Day 1

Eligibility
Key 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 more than or equal to 18 years at the time of signing informed
consent (in Algeria more than or equal to 19 years; in Japan more than or equal to 20
years).

- Diagnosed with T2DM more than or equal to 180 days prior to the day of signing the
informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Brookvale
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Campbelltown
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Coffs Harbour
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Maroubra
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Herston
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Morayfield
Recruitment hospital [9] 0 0
Novo Nordisk Investigational Site - North Ipswich
Recruitment hospital [10] 0 0
Novo Nordisk Investigational Site - Sherwood
Recruitment hospital [11] 0 0
Novo Nordisk Investigational Site - Victoria Point
Recruitment hospital [12] 0 0
Novo Nordisk Investigational Site - Forest Hill
Recruitment hospital [13] 0 0
Novo Nordisk Investigational Site - Moonee Ponds
Recruitment hospital [14] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [15] 0 0
Novo Nordisk Investigational Site - Preston
Recruitment hospital [16] 0 0
Novo Nordisk Investigational Site - Ringwood
Recruitment hospital [17] 0 0
Novo Nordisk Investigational Site - Fremantle
Recruitment hospital [18] 0 0
Novo Nordisk Investigational Site - Geelong
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
2035 - Maroubra
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4506 - Morayfield
Recruitment postcode(s) [9] 0 0
4305 - North Ipswich
Recruitment postcode(s) [10] 0 0
4075 - Sherwood
Recruitment postcode(s) [11] 0 0
4165 - Victoria Point
Recruitment postcode(s) [12] 0 0
3131 - Forest Hill
Recruitment postcode(s) [13] 0 0
3039 - Moonee Ponds
Recruitment postcode(s) [14] 0 0
3052 - Parkville
Recruitment postcode(s) [15] 0 0
3072 - Preston
Recruitment postcode(s) [16] 0 0
3134 - Ringwood
Recruitment postcode(s) [17] 0 0
6160 - Fremantle
Recruitment postcode(s) [18] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
Algeria
State/province [1] 0 0
Algiers
Country [2] 0 0
Algeria
State/province [2] 0 0
Batna
Country [3] 0 0
Algeria
State/province [3] 0 0
Constantine
Country [4] 0 0
Algeria
State/province [4] 0 0
Tiaret
Country [5] 0 0
Algeria
State/province [5] 0 0
Tizi Ouzou
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Caba
Country [8] 0 0
Argentina
State/province [8] 0 0
Chacabuco
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Argentina
State/province [10] 0 0
Coronel Suarez
Country [11] 0 0
Argentina
State/province [11] 0 0
Córdoba
Country [12] 0 0
Argentina
State/province [12] 0 0
Godoy Cruz
Country [13] 0 0
Argentina
State/province [13] 0 0
Lanus Este
Country [14] 0 0
Argentina
State/province [14] 0 0
Mar del Plata
Country [15] 0 0
Argentina
State/province [15] 0 0
Morón
Country [16] 0 0
Brazil
State/province [16] 0 0
Ceara
Country [17] 0 0
Brazil
State/province [17] 0 0
Goias
Country [18] 0 0
Brazil
State/province [18] 0 0
Minas Gerais
Country [19] 0 0
Brazil
State/province [19] 0 0
Parana
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio Grande Do Sul
Country [21] 0 0
Brazil
State/province [21] 0 0
Sao Paulo
Country [22] 0 0
Brazil
State/province [22] 0 0
Fortaleza
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Gansu
Country [25] 0 0
China
State/province [25] 0 0
Guangdong
Country [26] 0 0
China
State/province [26] 0 0
Guizhou
Country [27] 0 0
China
State/province [27] 0 0
Jiangsu
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Sichuan
Country [30] 0 0
China
State/province [30] 0 0
Zhejiang
Country [31] 0 0
China
State/province [31] 0 0
Nanjing
Country [32] 0 0
Israel
State/province [32] 0 0
Bat Yam
Country [33] 0 0
Israel
State/province [33] 0 0
Beer sheva
Country [34] 0 0
Israel
State/province [34] 0 0
Beer-Sheva HaDarom
Country [35] 0 0
Israel
State/province [35] 0 0
Bnei Brak
Country [36] 0 0
Israel
State/province [36] 0 0
Haifa
Country [37] 0 0
Israel
State/province [37] 0 0
Holon
Country [38] 0 0
Israel
State/province [38] 0 0
Jerusalem
Country [39] 0 0
Israel
State/province [39] 0 0
Kiryat Bialik
Country [40] 0 0
Israel
State/province [40] 0 0
Nahariya
Country [41] 0 0
Israel
State/province [41] 0 0
Nazareth
Country [42] 0 0
Israel
State/province [42] 0 0
Petach Tikva
Country [43] 0 0
Israel
State/province [43] 0 0
Petah-Tikva
Country [44] 0 0
Israel
State/province [44] 0 0
Ra'anana
Country [45] 0 0
Israel
State/province [45] 0 0
Tel Aviv
Country [46] 0 0
Israel
State/province [46] 0 0
Tel-Aviv
Country [47] 0 0
Israel
State/province [47] 0 0
Zefat
Country [48] 0 0
Japan
State/province [48] 0 0
Chiba-shi, Chiba
Country [49] 0 0
Japan
State/province [49] 0 0
Chuo-ku, Tokyo
Country [50] 0 0
Japan
State/province [50] 0 0
Ebina-shi, Kanagawa
Country [51] 0 0
Japan
State/province [51] 0 0
Fukushima
Country [52] 0 0
Japan
State/province [52] 0 0
Hamamatsu-Shi Shizuoka
Country [53] 0 0
Japan
State/province [53] 0 0
Hokkaido
Country [54] 0 0
Japan
State/province [54] 0 0
Kanagawa
Country [55] 0 0
Japan
State/province [55] 0 0
Kawagoe-shi, Saitama
Country [56] 0 0
Japan
State/province [56] 0 0
Koshigaya-shi,Saitama
Country [57] 0 0
Japan
State/province [57] 0 0
Kumamoto
Country [58] 0 0
Japan
State/province [58] 0 0
Mito-shi, Ibaraki
Country [59] 0 0
Japan
State/province [59] 0 0
Miyazaki
Country [60] 0 0
Japan
State/province [60] 0 0
Nishi-ku Sapporo
Country [61] 0 0
Japan
State/province [61] 0 0
Oita-shi
Country [62] 0 0
Japan
State/province [62] 0 0
Okawa-shi, Fukuoka
Country [63] 0 0
Japan
State/province [63] 0 0
Ota-ku, Tokyo
Country [64] 0 0
Japan
State/province [64] 0 0
Oyama-shi
Country [65] 0 0
Japan
State/province [65] 0 0
Shimotsuke-shi, Tochigi
Country [66] 0 0
Japan
State/province [66] 0 0
Shinjyuku-ku Tokyo
Country [67] 0 0
Mexico
State/province [67] 0 0
Baja California Norte
Country [68] 0 0
Mexico
State/province [68] 0 0
Coahuila
Country [69] 0 0
Mexico
State/province [69] 0 0
Estado De México
Country [70] 0 0
Mexico
State/province [70] 0 0
Guanajuato
Country [71] 0 0
Mexico
State/province [71] 0 0
Guerrero
Country [72] 0 0
Mexico
State/province [72] 0 0
Jalisco
Country [73] 0 0
Mexico
State/province [73] 0 0
Morelos
Country [74] 0 0
Mexico
State/province [74] 0 0
México, D.F.
Country [75] 0 0
Mexico
State/province [75] 0 0
Nuevo León
Country [76] 0 0
Mexico
State/province [76] 0 0
San Luis Potosi
Country [77] 0 0
Mexico
State/province [77] 0 0
Sinaloa
Country [78] 0 0
Mexico
State/province [78] 0 0
Sonora
Country [79] 0 0
Mexico
State/province [79] 0 0
Tamaulipas
Country [80] 0 0
Mexico
State/province [80] 0 0
Aguascalientes
Country [81] 0 0
Mexico
State/province [81] 0 0
Guadalajara
Country [82] 0 0
Mexico
State/province [82] 0 0
Mexico City
Country [83] 0 0
Mexico
State/province [83] 0 0
Monterrey
Country [84] 0 0
Mexico
State/province [84] 0 0
Queretaro
Country [85] 0 0
Mexico
State/province [85] 0 0
Veracruz
Country [86] 0 0
Saudi Arabia
State/province [86] 0 0
Al Ihsa
Country [87] 0 0
Saudi Arabia
State/province [87] 0 0
Buraydah
Country [88] 0 0
Saudi Arabia
State/province [88] 0 0
Jeddah
Country [89] 0 0
Saudi Arabia
State/province [89] 0 0
Riyadh
Country [90] 0 0
Saudi Arabia
State/province [90] 0 0
Taif
Country [91] 0 0
Turkey
State/province [91] 0 0
Adana
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
Turkey
State/province [93] 0 0
Antalya
Country [94] 0 0
Turkey
State/province [94] 0 0
Edirne
Country [95] 0 0
Turkey
State/province [95] 0 0
Elazig
Country [96] 0 0
Turkey
State/province [96] 0 0
Eskisehir
Country [97] 0 0
Turkey
State/province [97] 0 0
Istanbul
Country [98] 0 0
Turkey
State/province [98] 0 0
Izmir
Country [99] 0 0
Turkey
State/province [99] 0 0
Kayseri
Country [100] 0 0
Turkey
State/province [100] 0 0
Malatya
Country [101] 0 0
Turkey
State/province [101] 0 0
Tekirdag
Country [102] 0 0
Turkey
State/province [102] 0 0
Zonguldak

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to register the occurrence of cardiovascular disease among type 2
diabetes patients across ten countries across the world. 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 prescribed to them by their doctor. Participants'
participation will be one day/one visit at their doctor. The study will last for about 6
months in total.
Trial website
https://clinicaltrials.gov/show/NCT03811288
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Reporting Anchor and Disclosure (1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03811288