The Study of Men Born in 1943

Cardiovascular Diseases Clinical Trial

Official title:

The Study of Men Born in 1943 - A Longitudinal Cohort Study From Middle-Age and Onward

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03138122
• Other study ID #: SahlgrenskaUH/Östra
• Status: Active, not recruiting
• Start date: February 9, 1993
• Est. completion date: December 31, 2043

Study information

• Verified date: August 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A random sample a random sample of half of all men born in 1943 and living in the city of Gothenburg, Sweden, have been investigated in 1993 at 50 years of age and will be followed continuously with repeated re-examinations and follow-up concerning mortality and cardiovascular diseased. Out of 1463 invited men, 798 (54.5%) accepted the invitation and is included in this longitudinal cohort study.

Description:

In January 1993 a random sample of half of all men born in 1943 and living in the city of Gothenburg, Sweden, was selected and invited to participate a longitudinal observational cohort study. Out of 1463 invited men, 798 (54.5%) accepted the invitation and were examined for 1st time between February 1993 and June 1994. All participants, at 50 years of age, underwent a physical examination including anthropometric measurements, blood pressure and ECG. Several questionaires about previous diseases, life style, physical stress, family history, medications, symptoms and psychosocial factors were included. Blood samples were drawn from an antecubital vein after a nights fast. Basal laboratory analysis were performed. In addition several samples of whole blood, serum and plasma were stored in a freezer (-80○ Celsius) for later analysis.

In 2003, at 60 years of age, a 2nd examination was performed with similar methodology and examination´s. At this time 655 of the original 798 men participated.

A 3rd examination was performed between May 2014 and December 2014. In addition to physical examinations, questionnaires and laboratory analysis an echocardiographic examination, a sleep recording, screening for atrial fibrillation with thumb-EKG and investigation with Arteriography was added.

Echocardiographic examinations were performed by experienced cardiologist in accordance with clinical routine using ultrasound system (Vivid 7 Dimension, GE Medical systems, Horten, Norway), together with commercially available analysis software (GE Vingmed Ultrasound EchoPAC PC, General Electric Healthcare, Little Chalfont, UK) and in agreement with ESC guideline for echocardiography EAE recommendations.

The sleep recording was conducted for one night in the patients home using Apnélink, Apnélink plus or Apnélink air. All participants also answered the Epworth sleepiness scale (ESS) and the functional outcome of sleep questionnaire (FOSQ).

Screening for atrial fibrillation were performed using a thumb-ECG (Zenicor Medical System, Sweden), during a two week-period immediately after the physical examination. ECG was registered by the participants at their home, by placing their thumbs on two electrodes for 30 seconds two times a day, one time in the morning and one in the evening, and also additionally in case they experience any symptoms such as dizziness or palpitations, in a duration of a 2-week period.

In Sweden, all hospital admissions since 1978 are registered in the National Patient Register (NPR) and classified according to the International Classification of Diseases (ICD 8 until 1986; ICD 9 until 1996, ICD 10 since 1997 and continuing). At each examination, information about hospitalizations, medication and morbidity was obtained. During follow-up, death certificates, autopsy reports, and medical records were obtained and studied for all participants. Follow-up will be continues for each of the original 798 participants until death. New examinations will be performed every 5-10 years during follow-up.

Endpoints that are registered include: death, cause of death, myocardial infarction, ischemic heart disease, heart failure with reduced, mid-range and preserved ejection fraction, atrial fibrillation, cerebral infarction, cerebral haemorrhage, diabetes mellitus, deep vein thrombosis, pulmonary embolism, any cancer, fractures and dementia.

The study complies with the Declaration of Helsinki, and the study protocols was approved by the Ethical Committee of Gothenburg (DNR 157-93 in 1993, DNR: 67-03, in 2003 and DNR 649-13 in 2013).

Aims:

1. To study the incidence and prevalence of cardiovascular risk factors and cardiovascular diseases in a random sample from the general population.

2. To study secular trends in cardiovascular risk factors and cardiovascular diseases by comparing this cohort of men born in 1943 to other cohorts of men born in 1913, 1923, 1933, 1953 and 1963 living in the same geographic area and investigated using the same methodology.

3. To study risk factors for various cardiovascular diseases in a longitudinal cohort study.

In 2016 all men who participated in the 2014 examiniation was invited to a cognitive screening. In total 333 of these men particpated in the screening which included the following tests: Immediate and Delayed Text Recall, Symbol Digit Modalities Test (SDMT), reduced version of The Boston Naming Test, The Clox and Cube Test, The Token Test, Stroop III, Ray-Osterrieth Complex Figure Test (ROCF), F-A-S verbal fluency test. Parallel Serial Mental Operations (PaSMO), and Trailmaking A.

An additional aim was then added:

4. To study risk factors for dementia / cognitive impairment

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 798
• Est. completion date: December 31, 2043
• Est. primary completion date: December 31, 2043
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 50 Years

Eligibility

Inclusion Criteria:

• Men born in 1943 and living in the city of Gothenburg, Sweden

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Congestive Heart Failure
• Heart Failure
• Sleep Apnea

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital / Östra	Gothenburg	Västra Götaland Region

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular diseases	Alla major cardiovascular events including cardiovascular death, myocardial Infarction, congestive heart failure atrial fibrillation, stroke and venous thromboembolism	from date of first examination until the date of endpoint or date of death from any cause, whichever come first assessed up to 20, 30, 40 and 50 years
Secondary	Sleep apnoea syndrome	Apnoea and hypopnoea as well as desaturation defined according to guide lines for scoring sleep apnoea.	at 71 years of age