Cardiovascular DiseasesNCT00005472
Job Strain, Ambulatory Blood Pressure and Hypertension
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To analyze the association between an objective measure of "job strain" and risk of stroke, and change in ambulatory blood pressure. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Accident, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1996to Aug 1998
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To analyze the association between an objective measure of "job strain" and risk of stroke, and change in ambulatory blood pressure.
Read the detailed description
BACKGROUND:
Cardiovascular disease accounts for 43 percent of all deaths in the United States. Hypertension affects as many as 50 million Americans, however the causes of essential hypertension are not well known. A new CVD risk factor ("job strain") has emerged as a potential major cause of essential hypertension. By 1995, over 20 studies had found significant positive relationships between "job strain" and CVD, coronary heart disease, all-cause mortality or hypertension. "Job strain" is defined as high psychological workload demands combined with low"decision latitude". An expanded concept of "job strain" which included low workplace social support ("iso-strain") was developed and examined in the study.
Important questions remained to be answered about "job strain", CVD and hypertension. In most studies, "job strain" was only measured at one point in time, while, in fact, cumulative exposure to "job strain" was believed to be the risk factor. In addition, most studies relied on self-report measures of "job strain". Also, no studies specifically examined risk of stroke and "job strain".
DESIGN NARRATIVE:
Data from the Cornell University cohort study of Psychosocial Factors and Cardiovascular Disease and the Columbia University-Northern Manhattan Stroke Study were analyzed. The study had five specific aims, including to determine whether: blood pressure levels were associated with cumulative exposure to "job strain"; differences in blood pressure increases were associated with an objective measure of "job strain"; increased risk of stroke was associated with an objective measure of "job strain"; changes in psychological variables over time were associated with job characteristics; changes in CVD risk factors (other than hypertension) were associated with job characteristics.
Paul Landsbergis also constructed measures of cumulative exposure to "job strain" and determined their association with blood pressure, and analyzed the association between job characteristics and change in psychological variables and cardiovascular disease (CVD) risk factors.
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, Stroke, Hypertension, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1996
- Study completionAug 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Paul Landsbergis, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005472
- Sponsor's protocol ID
- 4954
- Other IDs
- R03HL055165
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Friedman R, Schwartz JE, Schnall PL, Landsbergis PA, Pieper C, Gerin W, Pickering TG. Psychological variables in hypertension: relationship to casual or ambulatory blood pressure in men. Psychosom Med. 2001 Jan-Feb;63(1):19-31. doi: 10.1097/00006842-200101000-00003.
PubMed 11211061Landsbergis 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.
PubMed 12448355Landsbergis 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.
PubMed 12828390Landsbergis PA, Schnall PL, Pickering TG, Warren K, Schwartz JE. Life-course exposure to job strain and ambulatory blood pressure in men. Am J Epidemiol. 2003 Jun 1;157(11):998-1006. doi: 10.1093/aje/kwg095.
PubMed 12777363
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Job Strain, Ambulatory Blood Pressure and Hypertension
- ClinicalTrials.gov ID
- NCT00005472
- Acronym / sponsor ID
- 4954
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1996
- Study completion
- Aug 1998 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyze the association between an objective measure of "job strain" and risk of stroke, and change in ambulatory blood pressure.
Detailed description
BACKGROUND:
Cardiovascular disease accounts for 43 percent of all deaths in the United States. Hypertension affects as many as 50 million Americans, however the causes of essential hypertension are not well known. A new CVD risk factor ("job strain") has emerged as a potential major cause of essential hypertension. By 1995, over 20 studies had found significant positive relationships between "job strain" and CVD, coronary heart disease, all-cause mortality or hypertension. "Job strain" is defined as high psychological workload demands combined with low"decision latitude". An expanded concept of "job strain" which included low workplace social support ("iso-strain") was developed and examined in the study.
Important questions remained to be answered about "job strain", CVD and hypertension. In most studies, "job strain" was only measured at one point in time, while, in fact, cumulative exposure to "job strain" was believed to be the risk factor. In addition, most studies relied on self-report measures of "job strain". Also, no studies specifically examined risk of stroke and "job strain".
DESIGN NARRATIVE:
Data from the Cornell University cohort study of Psychosocial Factors and Cardiovascular Disease and the Columbia University-Northern Manhattan Stroke Study were analyzed. The study had five specific aims, including to determine whether: blood pressure levels were associated with cumulative exposure to "job strain"; differences in blood pressure increases were associated with an objective measure of "job strain"; increased risk of stroke was associated with an objective measure of "job strain"; changes in psychological variables over time were associated with job characteristics; changes in CVD risk factors (other than hypertension) were associated with job characteristics.
Paul Landsbergis also constructed measures of cumulative exposure to "job strain" and determined their association with blood pressure, and analyzed the association between job characteristics and change in psychological variables and cardiovascular disease (CVD) risk factors.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 11211061Friedman R, Schwartz JE, Schnall PL, Landsbergis PA, Pieper C, Gerin W, Pickering TG. Psychological variables in hypertension: relationship to casual or ambulatory blood pressure in men. Psychosom Med. 2001 Jan-Feb;63(1):19-31. doi: 10.1097/00006842-200101000-00003.
- Background: PubMed 12448355Landsbergis 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.
- Background: PubMed 12828390Landsbergis 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.
- Background: PubMed 12777363Landsbergis PA, Schnall PL, Pickering TG, Warren K, Schwartz JE. Life-course exposure to job strain and ambulatory blood pressure in men. Am J Epidemiol. 2003 Jun 1;157(11):998-1006. doi: 10.1093/aje/kwg095.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Landsbergis
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, 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 NCT00005472, which also lists 4 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.