- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00005315
Psykosociale faktorer og hjerte-kar-sygdomme
At evaluere psykosociale faktorers rolle i udviklingen af hypertension og hjerte-kar-sygdomme.
At estimere forekomsten af maskeret hypertension og dens potentielle rolle i udviklingen af subklinisk kardiovaskulær sygdom At sammenligne pålideligheden af kontorblodtryk (BP), hjemme-BP og ambulatorisk BP og deres sammenhænge med subklinisk kardiovaskulær sygdom
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
DESIGN FORTÆLLING:
Undersøgelserne havde flere indbyrdes forbundne temaer. Den ene var at udforske sammenhængen mellem miljøstress og blodtryk over en række tidsforløb, med akutte laboratorieundersøgelser i den ene yderlighed og langsigtede prospektive undersøgelser i den anden. Den grundlæggende stressmodel omfattede tre elementer: stressfaktorens objektive natur, individets opfattelse af den og hans eller hendes fysiologiske modtagelighed. Denne model inkorporerede elementer fra Karasek Job Strain-modellen og Frankenhaueser-anstrengelses-nød-modellen med to komponenter svarende til efterspørgsel og kontrol. En tredje dimension var social støtte. Disse modeller blev testet under både laboratorie- og feltforhold. Blodtryk var den vigtigste afhængige variabel sammen med strukturelle ændringer i hjertet og halspulsårerne. Fem projekter blev inkluderet. Projekt l evaluerede ambulatorisk blodtryks og blodtryksvariabilitets evne til at forudsige kardiovaskulær morbiditet, og inkluderede også et tværsnitsstudie, der sammenlignede forholdet mellem blodtryk og målorganskader hos sorte og hvide individer. Hypotesen om, at hypertension i hvid pels er en tilstand forbundet med lavere risiko end vedvarende hypertension, blev også testet. Projekt 2 (Work Site Blood Pressure Study) evaluerede prospektivt virkningerne af arbejdsbelastning og social støtte på blodtryk og andre udfaldsvariable i en erhvervsaktiv befolkning. Projekt 3 undersøgte psykosociale og hormonelle faktorer, der påvirker daglige variationer af blodtryk hos kvinder, herunder ændringer i forbindelse med menstruation og overgangsalderen. Projekt 4 (The Masked Hypertension Study) vurderede forekomsten af maskeret hypertension (normalt blodtryk i klinikken, men forhøjet blodtryk i ens sædvanlige miljø) og dets sammenhæng med subklinisk kardiovaskulær sygdom (CVD); ~50% af prøven blev re-evalueret i gennemsnit 6 år senere. Projekt 5 (Forbedring af påvisning af hypertension) havde gentagne vurderinger af klinik-BP, hjemme-BP og ambulatorisk BP for at evaluere test-gentest-pålideligheden af hver og sammenligne deres associationer med subklinisk CVD.
Undersøgelsen blev fornyet i FY 1998, FY 2003 og i FY 2009 for at fortsætte opfølgning og analyse.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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24-timers ambulant blodtryk
Tidsramme: baseline og opfølgning (50 % af prøven, i gennemsnit 6,5 år senere)
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baseline og opfølgning (50 % af prøven, i gennemsnit 6,5 år senere)
|
|
|
venstre ventrikulære masseindeks
Tidsramme: tværsnit (baseline) og forandring (gennemsnitligt 6,5 år senere)
|
ved 2-D ekkokardiografi
|
tværsnit (baseline) og forandring (gennemsnitligt 6,5 år senere)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph Schwartz, PhD, Columbia University
Publikationer og nyttige links
Generelle publikationer
- James GD, Toledano T, Datz G, Pickering TG. Factors influencing the awake-sleep difference in ambulatory blood pressure: main effects and sex differences. J Hum Hypertens. 1995 Oct;9(10):821-6.
- Schnall PL, Schwartz JE, Landsbergis PA, Warren K, Pickering TG. A longitudinal study of job strain and ambulatory blood pressure: results from a three-year follow-up. Psychosom Med. 1998 Nov-Dec;60(6):697-706. doi: 10.1097/00006842-199811000-00007.
- Devereux RB, Bella J, Boman K, Gerdts E, Nieminen MS, Rokkedal J, Papademetriou V, Wachtell K, Wright J, Paranicas M, Okin PM, Roman MJ, Smith G, Dahlof B. Echocardiographic left ventricular geometry in hypertensive patients with electrocardiographic left ventricular hypertrophy: The LIFE Study. Blood Press. 2001;10(2):74-82. doi: 10.1080/08037050152112050.
- Devereux RB, Roman MJ, Palmieri V, Okin PM, Boman K, Gerdts E, Nieminen MS, Papademetriou V, Wachtell K, Dahlof B. Left ventricular wall stresses and wall stress-mass-heart rate products in hypertensive patients with electrocardiographic left ventricular hypertrophy: the LIFE study. Losartan Intervention For Endpoint reduction in hypertension. J Hypertens. 2000 Aug;18(8):1129-38. doi: 10.1097/00004872-200018080-00019.
- Liu JE, Roman MJ, Pini R, Schwartz JE, Pickering TG, Devereux RB. Cardiac and arterial target organ damage in adults with elevated ambulatory and normal office blood pressure. Ann Intern Med. 1999 Oct 19;131(8):564-72. doi: 10.7326/0003-4819-131-8-199910190-00003.
- Devereux RB, Pini R, Aurigemma GP, Roman MJ. Measurement of left ventricular mass: methodology and expertise. J Hypertens. 1997 Aug;15(8):801-9. doi: 10.1097/00004872-199715080-00002.
- Devereux RB. Do antihypertensive drugs differ in their ability to regress left ventricular hypertrophy? Circulation. 1997 Apr 15;95(8):1983-5. doi: 10.1161/01.cir.95.8.1983. No abstract available.
- Devereux RB, Agabiti-Rosei E, Dahlof B, Gosse P, Hahn RT, Okin PM, Roman MJ. Regression of left ventricular hypertrophy as a surrogate end-point for morbid events in hypertension treatment trials. J Hypertens Suppl. 1996 Sep;14(2):S95-101; discussion S101-2. doi: 10.1097/00004872-199609002-00018. Erratum In: J Hypertens 1997 Jan;15(1):103.
- Roman MJ, Pickering TG, Schwartz JE, Pini R, Devereux RB. Relation of arterial structure and function to left ventricular geometric patterns in hypertensive adults. J Am Coll Cardiol. 1996 Sep;28(3):751-6. doi: 10.1016/0735-1097(96)00225-2. Erratum In: J Am Coll Cardiol 1996 Nov 15;28(6):1642.
- Kim M, Roman MJ, Cavallini MC, Schwartz JE, Pickering TG, Devereux RB. Effect of hypertension on aortic root size and prevalence of aortic regurgitation. Hypertension. 1996 Jul;28(1):47-52. doi: 10.1161/01.hyp.28.1.47.
- Cavallini MC, Roman MJ, Blank SG, Pini R, Pickering TG, Devereux RB. Association of the auscultatory gap with vascular disease in hypertensive patients. Ann Intern Med. 1996 May 15;124(10):877-83. doi: 10.7326/0003-4819-124-10-199605150-00003.
- Saba PS, Roman MJ, Ganau A, Pini R, Jones EC, Pickering TG, Devereux RB. Relationship of effective arterial elastance to demographic and arterial characteristics in normotensive and hypertensive adults. J Hypertens. 1995 Sep;13(9):971-7. doi: 10.1097/00004872-199509000-00006.
- Gerin W, Pickering TG. Association between delayed recovery of blood pressure after acute mental stress and parental history of hypertension. J Hypertens. 1995 Jun;13(6):603-10. doi: 10.1097/00004872-199506000-00005.
- Roman MJ, Pickering TG, Pini R, Schwartz JE, Devereux RB. Prevalence and determinants of cardiac and vascular hypertrophy in hypertension. Hypertension. 1995 Aug;26(2):369-73. doi: 10.1161/01.hyp.26.2.369.
- Okin PM, Roman MJ, Devereux RB, Kligfield P. Electrocardiographic identification of increased left ventricular mass by simple voltage-duration products. J Am Coll Cardiol. 1995 Feb;25(2):417-23. doi: 10.1016/0735-1097(94)00371-v.
- Palmieri V, de Simone G, Roman MJ, Schwartz JE, Pickering TG, Devereux RB. Ambulatory blood pressure and metabolic abnormalities in hypertensive subjects with inappropriately high left ventricular mass. Hypertension. 1999 Nov;34(5):1032-40. doi: 10.1161/01.hyp.34.5.1032. Erratum In: Hypertension 2000 Jul;36(1):147.
- Saba PS, Roman MJ, Longhini C, Scorzoni D, Pini R, Devereux RB, Ganau A. Carotid intimal-medial thickness and stiffness are not affected by hypercholesterolemia in uncomplicated essential hypertension. Arterioscler Thromb Vasc Biol. 1999 Nov;19(11):2788-94. doi: 10.1161/01.atv.19.11.2788.
- Gerber LM, Schwartz JE, Schnall PL, Devereux RB, Warren K, Pickering TG. Effect of body weight changes on changes in ambulatory and standardized non-physician blood pressures over three years. Ann Epidemiol. 1999 Nov;9(8):489-97. doi: 10.1016/s1047-2797(99)00028-9.
- Kario K, Schwartz JE, Pickering TG. Ambulatory physical activity as a determinant of diurnal blood pressure variation. Hypertension. 1999 Oct;34(4 Pt 1):685-91. doi: 10.1161/01.hyp.34.4.685.
- Devereux RB, Okin PM, Roman MJ. Left ventricular hypertrophy as a surrogate end-point in hypertension. Clin Exp Hypertens. 1999 Jul-Aug;21(5-6):583-93. doi: 10.3109/10641969909060991.
- Saba PS, Ganau A, Devereux RB, Pini R, Pickering TG, Roman MJ. Impact of arterial elastance as a measure of vascular load on left ventricular geometry in hypertension. J Hypertens. 1999 Jul;17(7):1007-15. doi: 10.1097/00004872-199917070-00018.
- Bella JN, Roman MJ, Pini R, Schwartz JE, Pickering TG, Devereux RB. Assessment of arterial compliance by carotid midwall strain-stress relation in hypertension. Hypertension. 1999 Mar;33(3):793-9. doi: 10.1161/01.hyp.33.3.793.
- Bella JN, Roman MJ, Pini R, Schwartz JE, Pickering TG, Devereux RB. Assessment of arterial compliance by carotid midwall strain-stress relation in normotensive adults. Hypertension. 1999 Mar;33(3):787-92. doi: 10.1161/01.hyp.33.3.787.
- Slotwiner DJ, Devereux RB, Schwartz JE, Pickering TG, de Simone G, Ganau A, Saba PS, Roman MJ. Relation of age to left ventricular function in clinically normal adults. Am J Cardiol. 1998 Sep 1;82(5):621-6. doi: 10.1016/s0002-9149(98)00390-7.
- Devereux RB, Okin PM, Roman MJ. Pre-clinical cardiovascular disease and surrogate end-points in hypertension: does race influence target organ damage independent of blood pressure? Ethn Dis. 1998;8(2):138-48.
- de Simone G, Devereux RB, Kimball TR, Mureddu GF, Roman MJ, Contaldo F, Daniels SR. Interaction between body size and cardiac workload: influence on left ventricular mass during body growth and adulthood. Hypertension. 1998 May;31(5):1077-82. doi: 10.1161/01.hyp.31.5.1077.
- Devereux RB, de Simone G, Pickering TG, Schwartz JE, Roman MJ. Relation of left ventricular midwall function to cardiovascular risk factors and arterial structure and function. Hypertension. 1998 Apr;31(4):929-36. doi: 10.1161/01.hyp.31.4.929.
- Schwartz JE, Stone AA. Strategies for analyzing ecological momentary assessment data. Health Psychol. 1998 Jan;17(1):6-16. doi: 10.1037//0278-6133.17.1.6.
- Landsbergis PA, Schnall PL, Deitz DK, Warren K, Pickering TG, Schwartz JE. Job strain and health behaviors: results of a prospective study. Am J Health Promot. 1998 Mar-Apr;12(4):237-45. doi: 10.4278/0890-1171-12.4.237.
- Devereux RB, de Simone G, Roman MJ. Relations of left ventricular geometry and function to prognosis in hypertension. Adv Exp Med Biol. 1997;432:1-12. doi: 10.1007/978-1-4615-5385-4_1. No abstract available.
- Roman MJ, Pickering TG, Schwartz JE, Cavallini MC, Pini R, Devereux RB. Is the absence of a normal nocturnal fall in blood pressure (nondipping) associated with cardiovascular target organ damage? J Hypertens. 1997 Sep;15(9):969-78. doi: 10.1097/00004872-199715090-00007.
- de Simone G, Devereux RB, Daniels SR, Mureddu G, Roman MJ, Kimball TR, Greco R, Witt S, Contaldo F. Stroke volume and cardiac output in normotensive children and adults. Assessment of relations with body size and impact of overweight. Circulation. 1997 Apr 1;95(7):1837-43. doi: 10.1161/01.cir.95.7.1837.
- Belkic KL, Schnall PL, Landsbergis PA, Schwartz JE, Gerber LM, Baker D, Pickering TG. Hypertension at the workplace--an occult disease? The need for work site surveillance. Adv Psychosom Med. 2001;22:116-38. doi: 10.1159/000059280. No abstract available.
- James GD, Bovbjerg DH. Age and perceived stress independently influence daily blood pressure levels and variation among women employed in wage jobs. Am J Hum Biol. 2001 Mar-Apr;13(2):268-74. doi: 10.1002/1520-6300(200102/03)13:23.0.CO;2-Z.
- Kario K, James GD, Marion R, Ahmed M, Pickering TG. The influence of work- and home-related stress on the levels and diurnal variation of ambulatory blood pressure and neurohumoral factors in employed women. Hypertens Res. 2002 Jul;25(4):499-506. doi: 10.1291/hypres.25.499.
- Landsbergis PA, Schnall PL, Pickering TG, Schwartz JE. Validity and reliability of a work history questionnaire derived from the Job Content Questionnaire. J Occup Environ Med. 2002 Nov;44(11):1037-47. doi: 10.1097/00043764-200211000-00010.
- Hoshide Y, Kario K, Schwartz JE, Hoshide S, Pickering TG, Shimada K. Incomplete benefit of antihypertensive therapy on stroke reduction in older hypertensives with abnormal nocturnal blood pressure dipping (extreme-dippers and reverse-dippers). Am J Hypertens. 2002 Oct;15(10 Pt 1):844-50. doi: 10.1016/s0895-7061(02)03020-0.
- Kario K, Schwartz JE, Gerin W, Robayo N, Maceo E, Pickering TG. Psychological and physical stress-induced cardiovascular reactivity and diurnal blood pressure variation in women with different work shifts. Hypertens Res. 2002 Jul;25(4):543-51. doi: 10.1291/hypres.25.543.
- Lipsky SI, Pickering TG, Gerin W. World Trade Center disaster effect on blood pressure. Blood Press Monit. 2002 Aug;7(4):249. doi: 10.1097/00126097-200208000-00008. No abstract available.
- Gerber LM, Schwartz JE, Cedeno-Mero C, Warren K, Pickering TG. Association of urinary albumin concentration with casual and ambulatory blood pressure: a similar relationship in normotensive and hypertensive subjects. Blood Press Monit. 2001 Oct;6(5):245-51. doi: 10.1097/00126097-200110000-00004.
- Kario K, Schwartz JE, Davidson KW, Pickering TG. Gender differences in associations of diurnal blood pressure variation, awake physical activity, and sleep quality with negative affect: the work site blood pressure study. Hypertension. 2001 Nov;38(5):997-1002. doi: 10.1161/hy1101.095009.
- de Simone G, Devereux RB, Kimball TR, Roman MJ, Palmieri V, Celentano A, Daniels SR. Relation of heart rate to left ventricular dimensions in normotensive, normal-weight children, adolescents and adults. Ital Heart J. 2001 Aug;2(8):599-604.
- Roman MJ, Pickering TG, Schwartz JE, Pini R, Devereux RB. Relation of blood pressure variability to carotid atherosclerosis and carotid artery and left ventricular hypertrophy. Arterioscler Thromb Vasc Biol. 2001 Sep;21(9):1507-11. doi: 10.1161/hq0901.095149.
- Kario K, McEwen BS, Pickering TG. Disasters and the heart: a review of the effects of earthquake-induced stress on cardiovascular disease. Hypertens Res. 2003 May;26(5):355-67. doi: 10.1291/hypres.26.355.
- Landsbergis PA, Schnall PL, Pickering TG, Warren K, Schwartz JE. Lower socioeconomic status among men in relation to the association between job strain and blood pressure. Scand J Work Environ Health. 2003 Jun;29(3):206-15. doi: 10.5271/sjweh.723.
- Haas DC, Gerber LM, Shimbo D, Warren K, Pickering TG, Schwartz JE. A comparison of morning blood pressure surge in African Americans and whites. J Clin Hypertens (Greenwich). 2005 Apr;7(4):205-9; quiz 210-1. doi: 10.1111/j.1524-6175.2005.03503.x.
- Haas DC, Davidson KW, Schwartz DJ, Rieckmann N, Roman MJ, Pickering TG, Gerin W, Schwartz JE. Depressive symptoms are independently predictive of carotid atherosclerosis. Am J Cardiol. 2005 Feb 15;95(4):547-50. doi: 10.1016/j.amjcard.2004.10.032.
- Gerin W, Chaplin W, Schwartz JE, Holland J, Alter R, Wheeler R, Duong D, Pickering TG. Sustained blood pressure increase after an acute stressor: the effects of the 11 September 2001 attack on the New York City World Trade Center. J Hypertens. 2005 Feb;23(2):279-84. doi: 10.1097/00004872-200502000-00009.
- de Simone G, Daniels SR, Kimball TR, Roman MJ, Romano C, Chinali M, Galderisi M, Devereux RB. Evaluation of concentric left ventricular geometry in humans: evidence for age-related systematic underestimation. Hypertension. 2005 Jan;45(1):64-8. doi: 10.1161/01.HYP.0000150108.37527.57. Epub 2004 Nov 22.
- Devereux RB. Left ventricular mass and stroke. What is the connection? JAMA. 1994 Jul 6;272(1):71-2. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4078
- 5P01HL047540 (U.S. NIH-bevilling/kontrakt)
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