Psychosocial Risk Factors for Coronary Heart Disease in Swedish Women
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Coronary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005691
First Posted
May 25, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005691
Brief Title
Psychosocial Risk Factors for Coronary Heart Disease in Swedish Women
Study Type
Observational
2. Study Status
Record Verification Date
July 2001
Overall Recruitment Status
Completed
Study Start Date
September 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To study psychosocial risk factors for coronary heart disease in Swedish women.
Detailed Description
BACKGROUND:
The incidence of non-fatal myocardial infarction in Swedish women below age 60 increased during the past 20 years. Standard risk factor change includes a decrease in average systolic blood pressure and S-cholesterol but a moderate increase in smoking and diabetes prevalence. During the same time period Swedish women have 'moved' into the labor market, so that employment rates are now similar in Swedish men and women. However, women have kept the main responsibilities for household and child care. In spite of generous legislation for maternity leave and child care, the strains from multiple roles and responsibilities have probably increased in Swedish women. The study sought to provide an answer to: 1) which factors - biological and behavioral - influenced both the extent of and progress of coronary artery disease, 2) which physiological, biochemical, or neuroendocrine mechanisms participated in the process. In addition to conventional statistical methods, canonical correlations analyses were used to describe direct and indirect pathways of the pathogenesis. Furthermore, by means of the two comparison groups, information was obtained about the specific characteristics of the female psychosocial and behavioral coronary heart disease risk profile.
DESIGN NARRATIVE:
The role of social strain was studied within a broader psychosocial context including social networks, social supports, social skills, reciprocity, coping, stressors, chronic work strain, family structure, personality and behavior characteristics. These aspects were related to possible physiologic cardiovascular mechanisms including reactivity of and persistent elevated heart rates and blood pressure on ambulatory monitoring as well as cardiac dysrhythmia and silent or symptomatic ischemia. Psychoneuroendocrine pathways were also investigated. These included catecholamines, cortisol, prolactin, estrogen, testosterone, gastrin, somatostatin. Other biochemical measures included lipid profile, coagulation, thrombolysis and immune function. These examinations were applied to all women below age 60, living in the greater Stockholm area, with signs or symptoms of coronary heart disease. The women were followed and reexamined (including angiograms) after 2 to 2.5 years. They were compared to an equal number of age matched men and to an equal number of age matched healthy women from the same catchment area.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Coronary Disease
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
9316185
Citation
Horsten M, Wamala SP, Vingerhoets A, Orth-Gomer K. Depressive symptoms, social support, and lipid profile in healthy middle-aged women. Psychosom Med. 1997 Sep-Oct;59(5):521-8. doi: 10.1097/00006842-199709000-00009. Erratum In: Psychosom Med 1998 May-Jun;60(3):257.
Results Reference
background
PubMed Identifier
9327484
Citation
Wamala SP, Wolk A, Orth-Gomer K. Determinants of obesity in relation to socioeconomic status among middle-aged Swedish women. Prev Med. 1997 Sep-Oct;26(5 Pt 1):734-44. doi: 10.1006/pmed.1997.0199.
Results Reference
background
PubMed Identifier
9328547
Citation
Wamala SP, Wolk A, Schenck-Gustafsson K, Orth-Gomer K. Lipid profile and socioeconomic status in healthy middle aged women in Sweden. J Epidemiol Community Health. 1997 Aug;51(4):400-7. doi: 10.1136/jech.51.4.400. Erratum In: J Epidemiol Community Health 1998 May;52(3):340.
Results Reference
background
PubMed Identifier
9008445
Citation
Orth-Gomer K, Mittleman MA, Schenck-Gustafsson K, Wamala SP, Eriksson M, Belkic K, Kirkeeide R, Svane B, Ryden L. Lipoprotein(a) as a determinant of coronary heart disease in young women. Circulation. 1997 Jan 21;95(2):329-34. doi: 10.1161/01.cir.95.2.329.
Results Reference
background
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Psychosocial Risk Factors for Coronary Heart Disease in Swedish Women
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