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The Study of Men Born in 1943

17 août 2020 mis à jour par: Per-Olof Hansson, Sahlgrenska University Hospital, Sweden

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

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.

Aperçu de l'étude

Description détaillée

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

Type d'étude

Observationnel

Inscription (Réel)

798

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Västra Götaland Region
      • Gothenburg, Västra Götaland Region, Suède, 416 85
        • Sahlgrenska University Hospital / Östra

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans à 50 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cardiovascular diseases
Délai: 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
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sleep apnoea syndrome
Délai: at 71 years of age
Apnoea and hypopnoea as well as desaturation defined according to guide lines for scoring sleep apnoea.
at 71 years of age

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 février 1993

Achèvement primaire (Anticipé)

31 décembre 2043

Achèvement de l'étude (Anticipé)

31 décembre 2043

Dates d'inscription aux études

Première soumission

26 avril 2017

Première soumission répondant aux critères de contrôle qualité

28 avril 2017

Première publication (Réel)

3 mai 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 août 2020

Dernière vérification

1 août 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • SahlgrenskaUH/Östra

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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