Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03811288
Registration number
NCT03811288
Ethics application status
Date submitted
18/01/2019
Date registered
22/01/2019
Titles & IDs
Public title
An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes
Query!
Scientific title
A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation
Query!
Secondary ID [1]
0
0
U1111-1215-4005
Query!
Secondary ID [2]
0
0
NN2211-4446
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CAPTURE-IO
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Participants with a history of established cardiovascular disease (CVD)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Day 1
Query!
Secondary outcome [1]
0
0
Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
Query!
Assessment method [1]
0
0
Percentage of participants (yes/no). High risk: more than 20 percent over 10 years.
Query!
Timepoint [1]
0
0
Day 1
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/09/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
7548
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Blacktown
Query!
Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - Brookvale
Query!
Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - Campbelltown
Query!
Recruitment hospital [4]
0
0
Novo Nordisk Investigational Site - Coffs Harbour
Query!
Recruitment hospital [5]
0
0
Novo Nordisk Investigational Site - Maroubra
Query!
Recruitment hospital [6]
0
0
Novo Nordisk Investigational Site - Wollongong
Query!
Recruitment hospital [7]
0
0
Novo Nordisk Investigational Site - Herston
Query!
Recruitment hospital [8]
0
0
Novo Nordisk Investigational Site - Morayfield
Query!
Recruitment hospital [9]
0
0
Novo Nordisk Investigational Site - North Ipswich
Query!
Recruitment hospital [10]
0
0
Novo Nordisk Investigational Site - Sherwood
Query!
Recruitment hospital [11]
0
0
Novo Nordisk Investigational Site - Victoria Point
Query!
Recruitment hospital [12]
0
0
Novo Nordisk Investigational Site - Forest Hill
Query!
Recruitment hospital [13]
0
0
Novo Nordisk Investigational Site - Moonee Ponds
Query!
Recruitment hospital [14]
0
0
Novo Nordisk Investigational Site - Parkville
Query!
Recruitment hospital [15]
0
0
Novo Nordisk Investigational Site - Preston
Query!
Recruitment hospital [16]
0
0
Novo Nordisk Investigational Site - Ringwood
Query!
Recruitment hospital [17]
0
0
Novo Nordisk Investigational Site - Fremantle
Query!
Recruitment hospital [18]
0
0
Novo Nordisk Investigational Site - Geelong
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
2100 - Brookvale
Query!
Recruitment postcode(s) [3]
0
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [4]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [5]
0
0
2035 - Maroubra
Query!
Recruitment postcode(s) [6]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [7]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [8]
0
0
4506 - Morayfield
Query!
Recruitment postcode(s) [9]
0
0
4305 - North Ipswich
Query!
Recruitment postcode(s) [10]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [11]
0
0
4165 - Victoria Point
Query!
Recruitment postcode(s) [12]
0
0
3131 - Forest Hill
Query!
Recruitment postcode(s) [13]
0
0
3039 - Moonee Ponds
Query!
Recruitment postcode(s) [14]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [15]
0
0
3072 - Preston
Query!
Recruitment postcode(s) [16]
0
0
3134 - Ringwood
Query!
Recruitment postcode(s) [17]
0
0
6160 - Fremantle
Query!
Recruitment postcode(s) [18]
0
0
3220 - Geelong
Query!
Recruitment outside Australia
Country [1]
0
0
Algeria
Query!
State/province [1]
0
0
Algiers
Query!
Country [2]
0
0
Algeria
Query!
State/province [2]
0
0
Batna
Query!
Country [3]
0
0
Algeria
Query!
State/province [3]
0
0
Constantine
Query!
Country [4]
0
0
Algeria
Query!
State/province [4]
0
0
Tiaret
Query!
Country [5]
0
0
Algeria
Query!
State/province [5]
0
0
Tizi Ouzou
Query!
Country [6]
0
0
Argentina
Query!
State/province [6]
0
0
Buenos Aires
Query!
Country [7]
0
0
Argentina
Query!
State/province [7]
0
0
Caba
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Chacabuco
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Cordoba
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Coronel Suarez
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Córdoba
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Godoy Cruz
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Lanus Este
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Mar del Plata
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Morón
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Ceara
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Goias
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Minas Gerais
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Parana
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Rio Grande Do Sul
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Sao Paulo
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Fortaleza
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Beijing
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Gansu
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Guangdong
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Guizhou
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Jiangsu
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Shanghai
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Sichuan
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Zhejiang
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Nanjing
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
Bat Yam
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Beer sheva
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Beer-Sheva HaDarom
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Bnei Brak
Query!
Country [36]
0
0
Israel
Query!
State/province [36]
0
0
Haifa
Query!
Country [37]
0
0
Israel
Query!
State/province [37]
0
0
Holon
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Jerusalem
Query!
Country [39]
0
0
Israel
Query!
State/province [39]
0
0
Kiryat Bialik
Query!
Country [40]
0
0
Israel
Query!
State/province [40]
0
0
Nahariya
Query!
Country [41]
0
0
Israel
Query!
State/province [41]
0
0
Nazareth
Query!
Country [42]
0
0
Israel
Query!
State/province [42]
0
0
Petach Tikva
Query!
Country [43]
0
0
Israel
Query!
State/province [43]
0
0
Petah-Tikva
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Ra'anana
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Tel Aviv
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Tel-Aviv
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Zefat
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Chiba-shi, Chiba
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Chuo-ku, Tokyo
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Ebina-shi, Kanagawa
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Fukushima
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Hamamatsu-Shi Shizuoka
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Hokkaido
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Kanagawa
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Kawagoe-shi, Saitama
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Koshigaya-shi,Saitama
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Kumamoto
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Mito-shi, Ibaraki
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Miyazaki
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Nishi-ku Sapporo
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Oita-shi
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Okawa-shi, Fukuoka
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Ota-ku, Tokyo
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Oyama-shi
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Shimotsuke-shi, Tochigi
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Shinjyuku-ku Tokyo
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Baja California Norte
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Coahuila
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Estado De México
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
Guanajuato
Query!
Country [71]
0
0
Mexico
Query!
State/province [71]
0
0
Guerrero
Query!
Country [72]
0
0
Mexico
Query!
State/province [72]
0
0
Jalisco
Query!
Country [73]
0
0
Mexico
Query!
State/province [73]
0
0
Morelos
Query!
Country [74]
0
0
Mexico
Query!
State/province [74]
0
0
México, D.F.
Query!
Country [75]
0
0
Mexico
Query!
State/province [75]
0
0
Nuevo León
Query!
Country [76]
0
0
Mexico
Query!
State/province [76]
0
0
San Luis Potosi
Query!
Country [77]
0
0
Mexico
Query!
State/province [77]
0
0
Sinaloa
Query!
Country [78]
0
0
Mexico
Query!
State/province [78]
0
0
Sonora
Query!
Country [79]
0
0
Mexico
Query!
State/province [79]
0
0
Tamaulipas
Query!
Country [80]
0
0
Mexico
Query!
State/province [80]
0
0
Aguascalientes
Query!
Country [81]
0
0
Mexico
Query!
State/province [81]
0
0
Guadalajara
Query!
Country [82]
0
0
Mexico
Query!
State/province [82]
0
0
Mexico City
Query!
Country [83]
0
0
Mexico
Query!
State/province [83]
0
0
Monterrey
Query!
Country [84]
0
0
Mexico
Query!
State/province [84]
0
0
Queretaro
Query!
Country [85]
0
0
Mexico
Query!
State/province [85]
0
0
Veracruz
Query!
Country [86]
0
0
Saudi Arabia
Query!
State/province [86]
0
0
Al Ihsa
Query!
Country [87]
0
0
Saudi Arabia
Query!
State/province [87]
0
0
Buraydah
Query!
Country [88]
0
0
Saudi Arabia
Query!
State/province [88]
0
0
Jeddah
Query!
Country [89]
0
0
Saudi Arabia
Query!
State/province [89]
0
0
Riyadh
Query!
Country [90]
0
0
Saudi Arabia
Query!
State/province [90]
0
0
Taif
Query!
Country [91]
0
0
Turkey
Query!
State/province [91]
0
0
Adana
Query!
Country [92]
0
0
Turkey
Query!
State/province [92]
0
0
Ankara
Query!
Country [93]
0
0
Turkey
Query!
State/province [93]
0
0
Antalya
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Edirne
Query!
Country [95]
0
0
Turkey
Query!
State/province [95]
0
0
Elazig
Query!
Country [96]
0
0
Turkey
Query!
State/province [96]
0
0
Eskisehir
Query!
Country [97]
0
0
Turkey
Query!
State/province [97]
0
0
Istanbul
Query!
Country [98]
0
0
Turkey
Query!
State/province [98]
0
0
Izmir
Query!
Country [99]
0
0
Turkey
Query!
State/province [99]
0
0
Kayseri
Query!
Country [100]
0
0
Turkey
Query!
State/province [100]
0
0
Malatya
Query!
Country [101]
0
0
Turkey
Query!
State/province [101]
0
0
Tekirdag
Query!
Country [102]
0
0
Turkey
Query!
State/province [102]
0
0
Zonguldak
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novo Nordisk A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03811288
Query!
Trial related presentations / publications
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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Reporting Anchor and Disclosure (1452)
Query!
Address
0
0
Novo Nordisk A/S
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.novonordisk-trials.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03811288