Cardiovascular Diseases Clinical Trial
To estimate the relative risks of acute myocardial infarction (MI) and of stroke in postmenopausal users of estrogen/progestogen (E/P) combinations and to estimate the relative risks of MI and of stroke in users of estrogen alone.
BACKGROUND:
Post-menopausal hormone use is becoming increasingly widespread based on evidence of the
benefits of estrogen use for bone and the heart. However, because estrogen alone
substantially increases the risk of endometrial cancer, estrogen users who have not
undergone a hysterectomy are frequently also placed on a progestogen (E/P), a strategy that
reduces the likelihood of endometrial cancer when compared with use of estrogen alone. In
1991, there were almost no data on the risk of cardiovascular disease in post-menopausal
women who used E/P combinations.
DESIGN NARRATIVE:
The study had a case-control design, Cases were women hospitalized with MI or stroke in any
of nine participating Northern California Kaiser Permanente hospitals in a 36 month period.
For each case, one control, matched by year of birth, was selected at random from among
members of the Kaiser Permanente Health Plan who were expected to use the same nine
hospitals for their medical care. Information about use of estrogen, E/P combinations, past
use of oral contraceptives, menopause, hysterectomy and oophorectomy, demographics, general
health status, preventive health care, and cardiovascular risk factors were collected in
interviews done of the subjects or, for fatal cases, a surrogate. Information about then
current use of estrogen and E/P combinations were also gathered by reviewing medical
records.
The investigators used conditional logistic regression analysis to estimate the relative
risks of MI and of stroke in users of E/P combinations, taking into account prior
oophorectomy and other potential confounders. They also estimated the risks of acute MI and
of stroke in users of estrogen alone, accounting for prior oophorectomy and potential
confounders.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
;
N/A
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
| Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
| Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
| Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
| Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
| Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
| Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
| Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
| Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
| Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
| Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
| Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
| Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|