Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis
Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis
2 other identifiers
observational
177
1 country
1
Brief Summary
The study hypothesis (or theory) is that monthly loss of iron before menopause may reduce women's risk of hardening of the arteries, or atherosclerosis. This study uses noninvasive, noncontrast magnetic resonance imaging (MRI) of arteries in women entering menopause. This will help to determine if there is a correlation between iron accumulation and hardening of the arteries. In addition, blood levels of hormones will be measured to help show differences due to hormone levels vs. iron accumulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedApril 5, 2018
April 1, 2018
8.8 years
June 15, 2009
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
vessel wall changes over time that precede plaque buildup
baseline, 1-year follow-up and 2-year follow-up
Secondary Outcomes (1)
development of cardiovascular disease
annually for 4 years after baseline visit
Study Arms (1)
Perimenopausal women
Women at the beginning stages of menopause
Eligibility Criteria
Perimenopausal women
You may qualify if:
- women at least 40 yrs of age
- between 1 and 6 menstrual cycles in the past 12 months
- or more of the following risk factors: high blood pressure, diabetes, high cholesterol, smoking
- no known heart or vascular disease
You may not qualify if:
- any known cardiovascular disease such as coronary disease, peripheral vascular disease, heart failure
- contraindication to MRI scan (e.g. aneurysm clip, iron-containing metal)
- NOTE that orthopedic hardware is usually MRI-compatible. We will go over detailed screening before enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State Univeristy Medical Center
Columbus, Ohio, 43210, United States
Biospecimen
Serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Subha V Raman, MD
Ohio State University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 15, 2009
First Posted
June 16, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2018
Study Completion
March 1, 2018
Last Updated
April 5, 2018
Record last verified: 2018-04