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Cardiovascular DiseasesNCT00005260

Mechanisms Underlying Psychosocial Associations With Ischemic Heart Disease (Kuopio)

An observational study of Cardiovascular Diseases and Carotid Artery Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To examine the relationships among psychosocial factors and carotid atherosclerosis, myocardial ischemia, arrhythmias, and thrombosis. Read more about this study

Who is it for?
Ages Up to 100 years
How many people
Not given
Where
No sites listed yet
Study dates
Jul 1990to Aug 2002
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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

Read the 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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Medical subject headings
Cardiovascular Diseases, Carotid Artery Diseases, Arrhythmias, Cardiac, Myocardial Ischemia, Thrombosis, Heart Diseases, Atherosclerosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startJul 1990
  3. Study completionAug 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005260
Sponsor's protocol ID
1143
Other IDs
R01HL044199
Status last verified
Jul 2005
First submitted
25 May 2000
Last updated
13 May 2016
Results posted
No

Publications

  • Wilson TW, Cohen RD, Lachenbruch PA, Wu M, Kaplan GA, Salonen JT. Is the relationship between supine blood pressure and postural changes in blood pressure artefactual? Results from the Kuopio Ischemic Heart Disease Risk Factor Study. J Hypertens. 1995 Apr;13(4):421-6.

    PubMed 7629402

  • Lynch JW, Everson SA, Kaplan GA, Salonen R, Salonen JT. Does low socioeconomic status potentiate the effects of heightened cardiovascular responses to stress on the progression of carotid atherosclerosis? Am J Public Health. 1998 Mar;88(3):389-94. doi: 10.2105/ajph.88.3.389.

    PubMed 9518969

  • Salonen JT, Lakka TA, Lakka HM, Valkonen VP, Everson SA, Kaplan GA. Hyperinsulinemia is associated with the incidence of hypertension and dyslipidemia in middle-aged men. Diabetes. 1998 Feb;47(2):270-5. doi: 10.2337/diab.47.2.270.

    PubMed 9519724

  • Kamarck TW, Everson SA, Kaplan GA, Manuck SB, Jennings JR, Salonen R, Salonen JT. Exaggerated blood pressure responses during mental stress are associated with enhanced carotid atherosclerosis in middle-aged Finnish men: findings from the Kuopio Ischemic Heart Disease Study. Circulation. 1997 Dec 2;96(11):3842-8. doi: 10.1161/01.cir.96.11.3842.

    PubMed 9403606

  • Kauhanen J, Kaplan GA, Goldberg DE, Salonen JT. Beer binging and mortality: results from the Kuopio ischaemic heart disease risk factor study, a prospective population based study. BMJ. 1997 Oct 4;315(7112):846-51. doi: 10.1136/bmj.315.7112.846.

    PubMed 9353504

  • Lynch J, Helmrich SP, Lakka TA, Kaplan GA, Cohen RD, Salonen R, Salonen JT. Moderately intense physical activities and high levels of cardiorespiratory fitness reduce the risk of non-insulin-dependent diabetes mellitus in middle-aged men. Arch Intern Med. 1996 Jun 24;156(12):1307-14.

    PubMed 8651839

  • Everson SA, Kaplan GA, Goldberg DE, Salonen R, Salonen JT. Hopelessness and 4-year progression of carotid atherosclerosis. The Kuopio Ischemic Heart Disease Risk Factor Study. Arterioscler Thromb Vasc Biol. 1997 Aug;17(8):1490-5. doi: 10.1161/01.atv.17.8.1490.

    PubMed 9301625

  • Everson SA, Kauhanen J, Kaplan GA, Goldberg DE, Julkunen J, Tuomilehto J, Salonen JT. Hostility and increased risk of mortality and acute myocardial infarction: the mediating role of behavioral risk factors. Am J Epidemiol. 1997 Jul 15;146(2):142-52. doi: 10.1093/oxfordjournals.aje.a009245.

    PubMed 9230776

  • Lynch J, Krause N, Kaplan GA, Salonen R, Salonen JT. Workplace demands, economic reward, and progression of carotid atherosclerosis. Circulation. 1997 Jul 1;96(1):302-7. doi: 10.1161/01.cir.96.1.302.

    PubMed 9236449

  • Jennings JR, Kamarck T, Manuck S, Everson SA, Kaplan G, Salonen JT. Aging or disease? Cardiovascular reactivity in Finnish men over the middle years. Psychol Aging. 1997 Jun;12(2):225-38. doi: 10.1037//0882-7974.12.2.225.

    PubMed 9189982

  • Lynch J, Krause N, Kaplan GA, Tuomilehto J, Salonen JT. Workplace conditions, socioeconomic status, and the risk of mortality and acute myocardial infarction: the Kuopio Ischemic Heart Disease Risk Factor Study. Am J Public Health. 1997 Apr;87(4):617-22. doi: 10.2105/ajph.87.4.617.

    PubMed 9146441

  • Kauhanen J, Kaplan GA, Goldberg DD, Cohen RD, Lakka TA, Salonen JT. Frequent hangovers and cardiovascular mortality in middle-aged men. Epidemiology. 1997 May;8(3):310-4. doi: 10.1097/00001648-199705000-00014.

    PubMed 9115028

  • Tuomainen TP, Nyyssonen K, Salonen R, Tervahauta A, Korpela H, Lakka T, Kaplan GA, Salonen JT. Body iron stores are associated with serum insulin and blood glucose concentrations. Population study in 1,013 eastern Finnish men. Diabetes Care. 1997 Mar;20(3):426-8. doi: 10.2337/diacare.20.3.426.

    PubMed 9051399

  • Lynch JW, Kaplan GA, Salonen JT. Why do poor people behave poorly? Variation in adult health behaviours and psychosocial characteristics by stages of the socioeconomic lifecourse. Soc Sci Med. 1997 Mar;44(6):809-19. doi: 10.1016/s0277-9536(96)00191-8.

    PubMed 9080564

  • Kauhanen J, Kaplan GA, Cohen RD, Julkunen J, Salonen JT. Alexithymia and risk of death in middle-aged men. J Psychosom Res. 1996 Dec;41(6):541-9. doi: 10.1016/s0022-3999(96)00226-7.

    PubMed 9032717

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Carotid Artery Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005260, which also lists 76 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.

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