Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921011
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : April 5, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Subha Raman, Ohio State University

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.

Condition or disease

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
Actual Enrollment : 177 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis
Study Start Date : May 2009
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Perimenopausal women
Women at the beginning stages of menopause

Primary Outcome Measures :
  1. vessel wall changes over time that precede plaque buildup [ Time Frame: baseline, 1-year follow-up and 2-year follow-up ]

Secondary Outcome Measures :
  1. development of cardiovascular disease [ Time Frame: annually for 4 years after baseline visit ]

Biospecimen Retention:   Samples Without DNA
Serum, plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Perimenopausal women

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00921011

United States, Ohio
The Ohio State Univeristy Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Subha V Raman, MD Ohio State University

Responsible Party: Subha Raman, Professor of Medicine, Ohio State University Identifier: NCT00921011     History of Changes
Other Study ID Numbers: 2008H0308
R01HL095563 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Subha Raman, Ohio State University:
atherosclerosis risk

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases