Mechanisms Underlying Psychosocial Associations With Ischemic Heart Disease (Kuopio)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005260
First received: May 25, 2000
Last updated: July 11, 2005
Last verified: July 2005

May 25, 2000
July 11, 2005
July 1990
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Complete list of historical versions of study NCT00005260 on ClinicalTrials.gov Archive Site
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Mechanisms Underlying Psychosocial Associations With Ischemic Heart Disease (Kuopio)
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To examine the relationships among psychosocial factors and carotid atherosclerosis, myocardial ischemia, arrhythmias, and thrombosis.

BACKGROUND:

Considerable interest and controversy exist concerning the role of psychosocial factors in the pathogenesis of ischemic heart disease. Studies of the prevalence, incidence, and mortality from ischemic heart disease have implicated socioeconomic status, job strain, Type A behavior, hostility, social support, and other variables.

The study used baseline data previously collected as part of the Kuopio Ischemic Heart Disease Risk Factor Study conducted in eastern Finland by the Research Institute of Public Health and the Research Institute of Exercise Medicine, both in Kuopio, and the Finnish National Public Health Institute in Helsinki. The area of eastern Finland lies within the area of greatest morbidity and mortality from ischemic heart disease in Finland, was part of the reference area for the evaluation of the North Karelia Project, and is part of the World Health Organization MONICA project.

DESIGN NARRATIVE:

The study was longitudinal in design. Physical examinations were conducted at baseline and information collected on behavioral risk factors, medical history, and medications. Evaluations included a maximal exercise tolerance test, four day supervised food recordings, a broad set of hematological and chemical tests from fasting venous blood and two 24-hour urine samples. Holter monitoring and ultrasonography of the carotid arteries were performed in Cohort II only. Psychosocial measures included social support and network participation, socioeconomic status, job strain, Type A behavior pattern, and John Henryism. All members of Cohort II were re-examined three years post-baseline. Cohort I members were not re-examined because they did not undergo Holter monitoring and ultrasonography. Prevalence and ischemic heart disease incidence analyses were performed using both cohorts. Baseline psychosocial factors were examined in relation to study endpoints which included extent of carotid atherosclerosis, presence of ischemia on exercise, presence of arrhythmias, tendency toward blood clotting, four year progression of atherosclerosis, and incidence of fatal and non-fatal ischemic heart disease.

The study was renewed in 1997. Data from a baseline examination, a four-year re-examination, and a proposed one-year re-examination of ultrasonographically assessed carotid and femoral atherosclerosis, and surveillance for myocardial infarctions and other outcomes, will be used to examine the progression or incidence of these outcomes in relation to changes in behavioral, psychosocial and socioeconomic factors. It will also be possible to see to to what extent the input of these behavioral, psychosocial and socioeconomic factors on cardiovascular disease (CVD) in 1,600 men and women is mediated by lipid peroxidation, hemostatic factors, and cardiovascular reactivity. Finally, the investigators state that this will be the first population-based epidemiologic study to examine the association between a carefully developed set of measures of cardiovascular reactivity to stress and the progression of carotid atherosclerosis, risk of myocardial infarction and death, and development of hypertension. The cohorts had previously been all male. Women were added when the study was renewed in FY 1997.

Observational
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  • Cardiovascular Diseases
  • Carotid Artery Diseases
  • Arrhythmia
  • Myocardial Ischemia
  • Thrombosis
  • Heart Diseases
  • Atherosclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2002
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No eligibility criteria

Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00005260
1143
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: George Kaplan University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP