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History of Changes for Study: NCT03138122
The Study of Men Born in 1943
Latest version (submitted August 17, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 28, 2017 None (earliest Version on record)
2 April 2, 2019 Study Status
3 August 17, 2020 Study Status and Study Description
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Study NCT03138122
Submitted Date:  April 28, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: SahlgrenskaUH/Östra
Brief Title: The Study of Men Born in 1943
Official Title: The Study of Men Born in 1943 - A Longitudinal Cohort Study From Middle-Age and Onward
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2017
Overall Status: Active, not recruiting
Study Start: February 9, 1993
Primary Completion: December 31, 2043 [Anticipated]
Study Completion: December 31, 2043 [Anticipated]
First Submitted: April 26, 2017
First Submitted that
Met QC Criteria:
April 28, 2017
First Posted: May 3, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
April 28, 2017
Last Update Posted: May 3, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sahlgrenska University Hospital, Sweden
Responsible Party: Principal Investigator
Investigator: Per-Olof Hansson
Official Title: M.D, Ph.D.,
Affiliation: Sahlgrenska University Hospital, Sweden
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief 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.
Detailed 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.
Open or close this module Conditions
Conditions: Cardiovascular Risk Factor
Atrial Fibrillation
Congestive Heart Failure
Sleep Apnea
Cardiovascular Diseases
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 798 [Actual]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Cardiovascular diseases
[ Time Frame: 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 ]

Alla major cardiovascular events including cardiovascular death, myocardial Infarction, congestive heart failure atrial fibrillation, stroke and venous thromboembolism
Secondary Outcome Measures:
1. Sleep apnoea syndrome
[ Time Frame: at 71 years of age ]

Apnoea and hypopnoea as well as desaturation defined according to guide lines for scoring sleep apnoea.
Open or close this module Eligibility
Study Population: A random population sample consisting half of all men born in 1943 and living in the city of Gothenburg, Sweden was invited. . Out of 1463 invited men, 798 (54.5%) accepted participation.
Sampling Method: Probability Sample
Minimum Age: 50 Years
Maximum Age: 50 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Open or close this module Contacts/Locations
Locations: Sweden, Västra Götaland Region
Sahlgrenska University Hospital / Östra
Gothenburg, Västra Götaland Region, Sweden, 416 85
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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