Psychosocial Risk Factors for Coronary Heart Disease in Swedish Women

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005691
• Other study ID #: 4213
• Secondary ID: R01HL045785
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: March 15, 2016
• Start date: September 1992
• Est. completion date: August 1996

Study information

• Verified date: July 2001
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To study psychosocial risk factors for coronary heart disease in Swedish women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 1996
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

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. Erratum in: Psychosom Med 1998 May-Jun;60(3):257. — View Citation

Orth-Gomér K, Mittleman MA, Schenck-Gustafsson K, Wamala SP, Eriksson M, Belkic K, Kirkeeide R, Svane B, Rydén L. Lipoprotein(a) as a determinant of coronary heart disease in young women. Circulation. 1997 Jan 21;95(2):329-34. — View Citation

Wamala SP, Wolk A, Orth-Gomér 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. — View Citation

Wamala SP, Wolk A, Schenck-Gustafsson K, Orth-Gomér K. Lipid profile and socioeconomic status in healthy middle aged women in Sweden. J Epidemiol Community Health. 1997 Aug;51(4):400-7. Erratum in: J Epidemiol Community Health 1998 May;52(3):340. — View Citation