Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02993172 |
Other study ID # |
CCHS |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
December 9, 2016 |
Last updated |
December 14, 2016 |
Start date |
January 1976 |
Study information
Verified date |
December 2016 |
Source |
Bispebjerg Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
Denmark: Danish Dataprotection Agency |
Study type |
Observational
|
Clinical Trial Summary
The Copenhagen City Heart Study is an ongoing cardiovascular population study initiated in
1976 which has examined approximately 25,000 individuals from the general population. The
initial sample has been re-invited up to four times and supplemented by younger individuals.
The study includes questionnaires, clinical assessment and biomarkers. The population have
been followed in a number of outcome registries and more than 900 scientific papers have
been published.
Description:
The Copenhagen City Heart Study, also known as "Østerbroundersøgelsen", is a large
prospective cardio-vascular population study of 20,000 women and men that was launched in
1975 by Dr Peter Schnohr and Dr Gorm Jensen together with statistician Jørgen Nyboe and
Prof. A. Tybjærg Hansen.
The original purpose of the study was to focus on prevention of coronary heart disease and
stroke. During the years many other aspects have been added to the study: pulmonary
diseases, heart failure, arrhythmia, alcohol, arthrosis, eye diseases, allergy, epilepsia,
dementia, stress, vital exhaustion, social network, sleep-apnoe, ageing and genetics. In the
fourth and fifth wave of the examination echocardiography was included.
The Copenhagen City Heart Study has invited a random sample of the census population in an
area of central Copenhagen in five waves. The primary population was a random sample of
19,329 men and women 20-93 years old, drawn from a population of approximately 90,000
inhabitants aged 20 years or older living in a central part of Copenhagen (Østerbro). Using
the unique personal identification number (Central-Personal-Register-code), consisting of
date of birth and a registration number, the sample was age-stratified within 5-year age
groups, with the main emphasis on the age groups from 35 to 70 years. The total number of
participants invited to the first four examinations was: 19,329+500+3,000+1,062 = 23,891 men
and women. Of the original 14,223 examined at the first examination 3,092 (21.7%) have been
examined in all four examinations.
Follow-up of mortality and morbidity using the unique personal identification number is
performed by linkage to a number of nation-wide disease registries. Follow-up completion
rate is almost 100 percent (less than 0.1% have been lost to follow-up mainly through
emigration), which is very uncommon for large population studies.
Overview of the patients examined in the Copenhagen City Heart Study:
1. st exam: 1976-78, 19,329 invited, 14,223 (73.6%) attended
2. nd exam: 1981-83, 18,059 invited, 12,698 (71.2%) attended
3. rd exam: 1991-94, 16,563 invited, 10.135 (61.2%) attended
4. th exam: 2001-03,12,600 invited, 6,238 (49.5%) attended
5. th exam: 2011-2014, approx 10,000 invited, approx 5000 (50%) attended
The Copenhagen City Heart Study is governed by a Steering Committee. The data from the
Copenhagen City Heart Study is made available to researchers upon application to and
approval by the Steering Committee. The following constitute the Steering Committee:
Gorm Jensen and Peter Schnohr (initiators), Peter Lange, Eva Prescott, Børge Nordestgaard,
Morten Grønbæk, Anne Tybjærg Hansen, Stig Bojesen, Finn Gyntelberg, Jan Skov Jensen and
Merete Appleyard