Physicians' Health Study: Study of Low Cardiovascular Disease Mortality

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005252
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: August 2004
  Purpose

To explain the extremely low cardiovascular mortality among Physicians' Health Study (PHS) participants by ascertaining all cardiovascular and total deaths among the 90,457 physicians who returned enrollment forms but were not randomized into the study. Also, to compare the mortality experience of randomized physicians with various subgroups of non-participants.


Condition
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: January 1990
Estimated Study Completion Date: December 1992
Detailed Description:

BACKGROUND:

The Physicians' Health Study was a randomized, double-blind, placebo-controlled primary prevention trial designed to test whether 325 mg aspirin every other day reduced the risk of cardiovascular disease and whether 50 mg beta-carotene on alternate days decreased cancer incidence among 22,071 male physicians, aged 40-84 years in 1982. On December 18, 1987, the external Data Monitoring Board recommended early termination of the blinded aspirin component of the trial, based on the emergence of a statistically extreme benefit of aspirin on both fatal and nonfatal myocardial infarction, as well as the extraordinarily low cardiovascular mortality rates among study participants.

DESIGN NARRATIVE:

In January 1982, the Physicians' Health Study investigators purchased a tape from the American Medical Association that contained the names of all male physicians born between January 1, 1907 and December 31, 1942. The tape provided the basis for the invitation to join the trial. A new computer tape was purchased from the AMA that contained names, addresses, and dates of birth for all physicians registered as of December 1982, current and 1982 addresses, and any reported deaths. This tape was matched against Physician Health Study data files to eliminate those not on the original tape, as well as those known to be deceased at the time of the original mailing. When the match was complete, the results were a new tape that included names, most recent addresses, and dates of birth of all those who were invited to participate in the trial. A new master study tape was compiled that included all non-randomized potentially eligible respondents to the invitational mailing as well as a 35 percent random sample of the non-respondents. This group of 138,460 comprised the cohort. The National Death Index (NDI) was searched from January 1, 1982 to January 25, 1988, the official termination date of the trial for each physician in the cohort as well as for the 22,071 randomized participants. A copy of the death certificate was obtained from the state department of vital statistics for each death identified by the NDI in order to distinguish between vascular and non-vascular deaths. An Endpoints Committee, using death certificates and medical records in some cases, assigned the cause of death to be entered into the data base.

Analyses were performed comparing: all randomized versus all non-randomized respondents; those randomized versus those eligible but unwilling to participate; those randomized versus those initially willing and eligible who enrolled in an 18 week period but were excluded prior to randomization. Baseline data on the enrollment forms were examined to determine whether differences in mortality rates could be explained by differences in cardiovascular risk factors among the groups.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005252

Sponsors and Collaborators
Investigators
Investigator: Julie Buring Brigham and Women's Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005252     History of Changes
Other Study ID Numbers: 1134
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Infarction
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 29, 2014