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
  Purpose

To examine the relationships among psychosocial factors and carotid atherosclerosis, myocardial ischemia, arrhythmias, and thrombosis.


Condition
Cardiovascular Diseases
Carotid Artery Diseases
Arrhythmia
Myocardial Ischemia
Thrombosis
Heart Diseases
Atherosclerosis

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1990
Estimated Study Completion Date: August 2002
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005260

Sponsors and Collaborators
Investigators
Investigator: George Kaplan University of Michigan
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005260     History of Changes
Other Study ID Numbers: 1143
Study First Received: May 25, 2000
Last Updated: July 11, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Arteriosclerosis
Thrombosis
Myocardial Ischemia
Coronary Artery Disease
Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Coronary Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014