Myocardial Infarction and Current Oral Contraceptive Use

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005241
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: June 2001
  Purpose

To assess whether current oral contraceptive (OC) use (within the previous month) increased the risk of myocardial infarction. Also, to assess the combined effects of cigarette smoking and oral contraceptive use.


Condition
Cardiovascular Diseases
Coronary Disease
Myocardial Infarction
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Natural History

Resource links provided by NLM:


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

Study Start Date: April 1989
Estimated Study Completion Date: December 1999
Detailed Description:

BACKGROUND:

It has been established that oral contraceptive formulations used in the 1960s and 1970s increased the risks of myocardial infarction, venous thromboembolism, and stroke. Oral contraceptive formulations have changed, as have prescribing practices, and there was a need for information on the effects of the newer formulations in use. Myocardial infarction is the most important cardiovascular disease in terms of the incidence and mortality attributed to use of oral contraceptives; although the overall incidence of myocardial infarction is relatively low in women of childbearing ages, the incidence is not low in smokers.

DESIGN NARRATIVE:

A case-control design was used. The case series consisted of women 18 to 44 years of age admitted for a documented first myocardial infarction to any of 100 collaborating hospitals in Massachusetts, Rhode Island, and Pennsylvania. Nurse interviewers administered standard structured questionnaires to cases and controls on drug use, race, religion, medical history and myocardial infarction risk factors. Information was collected on: cigarette smoking; histories of hypertension, diabetes mellitus, angina, abnormal plasma lipids; reproductive and menstrual histories; alcohol and coffee consumption; personality type using the Framingham Type A scale; family history of myocardial infarction; exercise; education and occupation of the patient and her spouse. Information was also obtained on the timing and duration of oral contraceptive use. The effect of oral contraceptive use was considered among nonsmokers, light smokers, and heavy smokers. Individual oral contraceptive formulations were classified according to dosage and type of estrogen, formulation type, and other groupings. Multiple logistic regression analysis with fitting of the regression equations by the method of maximum likelihood was used for simultaneous control of all potential confounding factors.

The study was renewed in 1995 to continue data collection to establish the effect of triphasic OCs on MI risk, with particular attention to the joint effect with heavy smoking. The new data collection also permitted more definitive analysis of the effect of monophasic OCs. Triphasic formulations have become popular and in 1995 accounted for about half of OC use. There were not enough users of triphasic OCs in the present study for informative analysis, nor were there any data from other studies on this issue. The study ended in December, 1999.

  Eligibility

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

No eligibility criteria

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005241     History of Changes
Other Study ID Numbers: 1122
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
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014