Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005241
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Myocardial Infarction and Current Oral Contraceptive Use
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL042483 | NIH | None | httpsreporternihgovquickSearchR01HL042483 |