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Health Professionals Follow-up Study

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ClinicalTrials.gov Identifier: NCT00005182
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Eric B. Rimm, Harvard School of Public Health (HSPH)

Study Description
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Brief Summary:
To test the hypothesis that increased risk of coronary heart disease, stroke, peripheral vascular disease, and cancer is related to diets high in saturated fat, animal protein, and hydrogenated vegetable oil, and low in polyunsaturated fat, fiber, vitamins A, C, and E, calcium, selenium, and chromium.

Condition or disease
Cardiovascular Diseases Cerebrovascular Accident Coronary Disease Peripheral Vascular Diseases Heart Diseases Myocardial Infarction

Detailed Description:

BACKGROUND:

The diet-heart hypothesis, that high dietary saturated fat and cholesterol intake increase the risk and high polyunsaturated fat reduces the risk of coronary heart disease in man is supported by ecologic studies, by experiments in rodents and non-human primates, by voluminous literature relating dietary factors to serum lipids, by several secondary prevention trials, and by the Lipid Research Clinics Trial demonstrating a reduction in coronary heart disease among participants assigned to cholestyramine.

Despite the substantial scientific interest and the obvious public health implications of the diet and heart disease issue, relatively few observational cohort or case-control investigations had been published prior to 1985. Although these observational studies were not entirely consistent, taken collectively, they tended to provide important general support for the diet-heart hypothesis. However, due to study design, limited numbers of endpoints, or methods of analysis, many central questions remained unanswered. The most important issue was the quantitative relationship between specific dietary factors and risk of coronary heart disease. Moreover, the interplay of dietary and genetic factors is poorly understood.

DESIGN NARRATIVE:

In this prospective cohort study, participants completed a mailed general medical and health questionnaire at baseline and an intensively validated semiquantitative food frequency questionnaire (SFFQ). At one year, tissue specimens were collected and catalogued for future nested case-control analyses of coronary heart disease risk in relation to levels of calcium, selenium, and chromium. Follow-up questionnaires to update exposure information and ascertain non-fatal endpoints were mailed at two-year intervals. All reported cases of non-fatal myocardial infarction, stroke, and cancer were documented with hospital records and/or pathology reports. Fatal events were ascertained with the National Death Index and documented. To standardize SFFQ nutrient scores against measurements of absolute intake, two one-week diet records were obtained from a random sample of 150 Boston-area participants.

The study was renewed in 1991, 1997, and in 2003 to continue the follow-up of 51,529 male health professionals. The cohort is followed by questionnaires mailed at two-year intervals to update exposure information and ascertain nonfatal events. Complete dietary assessments are included every four years.A subset of 18,225 participants provided blood samples between 1993 and 1995. Genotyping was performed among 435 cardiovascular disease cases and 878 controls using Affymetrix 6.0 platform.

Study Design
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Study Type : Observational
Actual Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 1985
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incident CVD [ Time Frame: Renewed every 5 years since 1986 ]

Biospecimen Retention:   Samples With DNA
plasma, RBC, WBC

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male Health Professionals
Criteria
Recruited through their professional organizations or occupation from mailing house lists.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005182


Sponsors and Collaborators
Harvard School of Public Health (HSPH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Eric Rimm Harvard School of Public Health (HSPH)
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eric B. Rimm, Associate Professor, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier: NCT00005182    
Other Study ID Numbers: 1060
R00HL088372 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Stroke
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Vascular Diseases
Coronary Disease
Peripheral Vascular Diseases
Peripheral Arterial Disease
Infarction
Ischemia
 Pathologic Processes
Necrosis
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atherosclerosis