Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Myocardial Infarction and Past Oral Contraceptive Use

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005173
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: July 2000
  Purpose

To evaluate whether the long-term use of oral contraceptives, after discontinuation, was associated with an increased incidence of first nonfatal myocardial infarction among women above the age of 50.


Condition
Cardiovascular Diseases
Coronary Disease
Myocardial Infarction
Heart Diseases
Menopause
Postmenopause

Study Type: Observational

Resource links provided by NLM:


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

Study Start Date: April 1985
Estimated Study Completion Date: April 1989
Detailed Description:

BACKGROUND:

In the mid 1980s, it was known that current oral contraceptive use (in the preceding month) increased the risk of myocardial infarction three to four-fold. Evidence seemed to indicate that past use lasting a total of five or more years was associated with a residual two-fold increase in myocardial infarction risk among women 40 to 49 years old. Since the incidence of the disease started to become appreciable beyond age 49, it was of public health importance to reexamine the evidence in a data base which included women aged 50 or older to determine how long the increased risk persisted and whether it varied according to the formulation of the preparation used. An increase in risk that persisted after discontinuation of oral contraceptive use would have major public health implications since millions of women have used or will use oral contraceptives for long periods.

DESIGN NARRATIVE:

The design was that of a case-control study. Cases were identified by weekly telephone calls to the coronary care units of 78 hospitals in greater Boston, Southern Connecticut, and Westchester County. Nurse-interviewers administered standard interviews to cases convalescing on medical wards after discharge from coronary care units and to controls identified in the same hospitals. Histories of oral contraceptive use, including the timing and duration of use and the name of the preparations, were recorded along with information on other drug use and myocardial infarction risk factors such as cigarette smoking. Data were collected for three years.

  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.

No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005173     History of Changes
Other Study ID Numbers: 1048
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 27, 2014