Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis

Detailed Description

Atherosclerosis, or hardening of the arteries, is the underlying disease responsible for the vast majority of cardiovascular morbidity and mortality and afflicted over 30 million Americans in 2005. While the prevalence of atherosclerosis is similar in women and men, women enjoy a ~5-10 year lag in onset of cardiovascular events compared to men. After menopause, a state defined by marked reduction in ovarian hormone production, the incidence of events such as heart attack and stroke caused by atherosclerotic plaque rises up to threefold regardless of age range. This has prompted numerous investigations of hormone therapy (HT) to lower cardiovascular risk to premenopausal levels. Therapeutic trials, however, have not realized a cardiovascular benefit; in fact, initiating HT in large randomized trials did not decrease and possibly increased cardiovascular risk. Studies of coronary heart disease prevention have shown mixed results using estrogen alone vs. estrogen plus progestin, while studies of stroke prevention have consistently shown increased risk with HT. Clearly, different therapeutic interventions warrant consideration. This proposal seeks to investigate a novel perspective using longitudinal clinical studies in women at risk of atherosclerosis. The studies involve a new noncontrast, noninvasive MRI method with blood tests that measure cholesterol, hormone levels, and inflammation.

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Univeristy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Perimenopausal women

Description

Inclusion Criteria:

• women at least 40 yrs of age
• between 1 and 6 menstrual cycles in the past 12 months
• 2 or more of the following risk factors: high blood pressure, diabetes, high cholesterol, smoking
• no known heart or vascular disease

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Perimenopausal women; Women at the beginning stages of menopause

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
vessel wall changes over time that precede plaque buildup	baseline, 1-year follow-up and 2-year follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
development of cardiovascular disease	annually for 4 years after baseline visit

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Subha V Raman, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: June 15, 2009
• First Submitted That Met QC Criteria: June 15, 2009
• First Posted (Estimate): June 16, 2009

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; hypertension; smoking; hyperlipidemia; atherosclerosis risk
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 2008H0308; R01HL095563 (U.S. NIH Grant/Contract)